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BMJ Clinical Evidence logoLink to BMJ Clinical Evidence
. 2011 May 5;2011:1901.

Pressure ulcers

Madhuri Reddy 1
PMCID: PMC3217823  PMID: 21524319

Abstract

Introduction

Unrelieved pressure or friction of the skin, particularly over bony prominences, can lead to pressure ulcers in up to one third of people in hospitals or community care, and one fifth of nursing home residents. Pressure ulcers are more likely in people with reduced mobility and poor skin condition, such as older people or those with vascular disease.

Methods and outcomes

We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of preventive interventions in people at risk of developing pressure ulcers? What are the effects of treatments in people with pressure ulcers? We searched: Medline, Embase, The Cochrane Library, and other important databases up to June 2010 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Results

We found 64 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.

Conclusions

In this systematic review we present information relating to the effectiveness and safety of the following interventions: air-filled vinyl boots, air-fluidised supports, alternating-pressure surfaces (including mattresses), alternative foam mattresses, constant low-pressure supports, debridement, electric profiling beds, electrotherapy, hydrocellular heel supports, low-air-loss beds (including hydrotherapy beds), low-level laser therapy, low-tech constant-low-pressure supports, medical sheepskin overlays, nutritional supplements, orthopaedic wool padding, pressure-relieving overlays on operating tables, pressure-relieving surfaces, repositioning (regular "turning"), seat cushions, standard beds, standard care, standard foam mattresses, standard tables, surgery, therapeutic ultrasound, topical lotions and dressings, topical negative pressure, and topical phenytoin.

Key Points

Unrelieved pressure or friction of the skin, particularly over bony prominences, can lead to pressure ulcers, which affect up to one third of people in hospitals or community care, and one fifth of nursing home residents.

  • Pressure ulcers are more likely in people with reduced mobility and poor skin condition, such as older people or those with vascular disease.

Alternative foam mattresses (such as viscoelastic foam) reduce the incidence of pressure ulcers in people at risk compared with standard hospital foam mattresses, although we don't know which is the best alternative to use.

Hydrocellular heel supports may decrease the risk of pressure ulcers compared with orthopaedic wool padding, but air-filled vinyl boots with foot cradles and low-air-loss hydrotherapy beds may increase the risk of ulcers compared with other pressure-relieving surfaces.

In people with pressure ulcers, air-fluidised supports may improve healing compared with standard care, although they can make it harder for people to get in and out of bed independently.

We don't know whether healing is improved in people with pressure ulcers by use of other treatments such as one specific specialised support surface (including alternating-pressure surfaces, low-tech constant-low-pressure supports, low-air-loss beds, and specific seat cushions) over any other specific specialised support surface, one specific wound dressing over any other specific wound dressing, or with surgery, electrotherapy, ultrasound, low-level laser therapy, topical negative pressure, topical phenytoin, or nutritional interventions.

About this condition

Definition

Pressure ulcers (also known as pressure sores, bed sores, and decubitus ulcers) may present as persistently hyperaemic, blistered, broken, or necrotic skin, and may extend to underlying structures, including muscle and bone. Pressure ulcers are usually graded on a scale of 1 to 4, with a higher grade indicating greater ulcer severity.

Incidence/ Prevalence

Reported prevalence rates range from 4.7% to 32.1% for hospital populations, 4.4% to 33.0% for community-care populations, and 4.6% to 20.7% for nursing-home populations.

Aetiology/ Risk factors

Pressure ulcers are caused by unrelieved pressure, shear, or friction. They are most common below the waist and at bony prominences, such as the sacrum, heels, and hips. They occur in all healthcare settings. Increased age, reduced mobility, impaired nutrition, vascular disease, faecal incontinence, and skin condition at baseline consistently emerge as risk factors. However, the relative importance of these and other factors is uncertain.

Prognosis

There are few data on prognosis of untreated pressure ulcers. The presence of pressure ulcers has been associated with a two- to four-fold increased risk of death in elderly people and people in intensive care. However, pressure ulcers are a marker for underlying disease severity and other comorbidities, rather than an independent predictor of mortality.

Aims of intervention

To prevent formation of a pressure ulcer; heal existing pressure ulcers; and improve quality of life, with minimal adverse effects of treatment.

Outcomes

Prevention of pressure ulcers, severity of pressure ulcers. Healing rates: rate of change of area and volume, time to heal, severity of pressure ulcers. Adverse effects of treatment. Interface pressure recorded at various anatomical sites is a surrogate outcome that is sometimes used in studies of preventive interventions, but has not yet been linked to clinical outcomes.

Methods

Clinical Evidence search and appraisal June 2010. The following databases were used to identify studies for this systematic review: Medline 1966 to June 2010, Embase 1980 to June 2010, and The Cochrane Database of Systematic Reviews, May 2010 [online] (1966 to date of issue). When editing this review we used The Cochrane Database of Systematic Reviews 2010, Issue 2. An additional search within The Cochrane Library was carried out for the Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment (HTA). We also searched for retractions of studies included in the review. Abstracts of the studies retrieved from the initial search were assessed by an information specialist. Selected studies were then sent to the contributor for additional assessment, using predetermined criteria to identify relevant studies. Study design criteria for inclusion in this review were: published systematic reviews of RCTs and RCTs in any language, with any level of blinding, and containing any number of individuals with any level of loss to follow-up. There was no minimum length of follow-up required to include studies. We included studies described as "open", "open label", and not blinded. We included systematic reviews of RCTs and RCTs where harms of an included intervention were studied applying the same study design criteria for inclusion as we did for benefits. We reviewed all RCTs that used objective clinical outcome measures. For many trials we could not be sure that the size of pressure ulcers was distributed evenly between groups at baseline. Unequal distribution of wound size at baseline would have an impact on all measures of wound healing. Ideally, studies of treatment should stratify randomisation by initial wound area and include enough participants to ensure even distribution of baseline wound size. A further difficulty in assessing the trials of pressure ulcer prevention and treatment is that it can be difficult to determine from reports whether an RCT of a new device, for example a mattress, is sufficiently similar to be assessed with previously described mattresses, or whether it constitutes a new device. It can therefore be difficult to combine data from RCTs and assess overall effects of treatment options. In addition we use a regular surveillance protocol to capture harms alerts from organisations such as the FDA and the MHRA, which are added to the reviews as required. To aid readability of the numerical data in our reviews, we round many percentages to the nearest whole number. Readers should be aware of this when relating percentages to summary statistics such as relative risks (RRs) and odds ratios (ORs). We have performed a GRADE evaluation of the quality of evidence for interventions included in this review (see table). The categorisation of the quality of the evidence (high, moderate, low, or very low) reflects the quality of evidence available for our chosen outcomes in our defined populations of interest. These categorisations are not necessarily a reflection of the overall methodological quality of any individual study, because the Clinical Evidence population and outcome of choice may represent only a small subset of the total outcomes reported, and population included, in any individual trial. For further details of how we perform the GRADE evaluation and the scoring system we use, please see our website (www.clinicalevidence.com).

Table.

GRADE Evaluation of interventions for Pressure ulcers.

Important outcomes Healing rates, Prevention of pressure ulcers
Studies (Participants) Outcome Comparison Type of evidence Quality Consistency Directness Effect size GRADE Comment
What are the effects of preventive interventions in people at risk of developing pressure ulcers?
6 (2117) Prevention of pressure ulcers Foam alternatives versus standard hospital mattress 4 –1 0 0 0 Moderate Quality point deducted for incomplete reporting of results
5 (795) Prevention of pressure ulcers Different foam alternatives versus each other 4 –1 0 –2 0 Very low Quality point deducted for incomplete reporting of results. Directness points deducted for underpowered RCTs and small number of comparators
5 (1402) Prevention of pressure ulcers Pressure-relieving overlays on operating tables versus standard table alone 4 −1 −1 −1 0 Very low Quality point deducted for weak methods. Consistency point deducted for conflicting results between RCTs. Directness point deducted for early termination of 1 RCT
3 (283) Prevention of pressure ulcers Low-air-loss beds versus standard intensive-care beds/alternating-pressure mattresses 4 –2 0 0 0 Low Quality points deducted for incomplete reporting of intervention and weak methods
2 (730) Prevention of pressure ulcers Medical sheep skin overlays versus standard care 4 0 0 –2 +1 Moderate Directness points deducted for selective exclusion of high-risk participants and no intention-to-treat analysis. Effect size point added for RR <0.5
2 (409) Prevention of pressure ulcers Alternating-pressure surfaces versus standard foam mattress 4 −3 0 −1 +1 Very low Quality points deducted for unclear allocation concealment, blinding, and incomplete reporting of results. Directness point deducted for no intention-to-treat analysis. Effect size point added for RR <0.5
10 (1606) Prevention of pressure ulcers Alternating-pressure surfaces versus constant-low-pressure supports 4 −1 0 −1 0 Low Quality point deducted for weak methods. Directness point deducted for unclear clinical relevance (heterogeneity in comparators, and wide confidence intervals not excluding clinically important effect)
4 (2153) Prevention of pressure ulcers Alternating-pressure surfaces versus each other 4 −1 0 −1 0 Low Quality point deducted for weak methods. Directness point deducted for 3 underpowered RCTs
4 (473) Prevention of pressure ulcers Seat cushions versus each other 4 –1 0 –1 0 Low Quality point deducted for weak methods. Directness point deducted for underpowered individual trials
1 (70) Prevention of pressure ulcers Electric profiling beds to prevent pressure ulcers versus standard hospital beds 4 –1 0 –1 0 Low Quality point deducted for sparse data. Directness point deducted for small number of events (no events in either group)
5 (1475) Prevention of pressure ulcers Nutritional supplements versus control 4 –3 0 –2 0 Very low Quality points deducted for unclear randomisation, lack of blinding, and high withdrawal rates. Directness points deducted for no intention-to-treat analysis and no between-group analysis in 1 RCT
4 (1055) Prevention of pressure ulcers Repositioning versus control, usually standard care 4 –2 0 –1 0 Very low Quality points deducted for weak methods and incomplete reporting of results. Directness point deducted for co-intervention in 1 RCT (change of mattress as well as frequency of repositioning)
1 (46) Prevention of pressure ulcers Repositioning at 30 degree tilt versus a 90 degree lateral and supine position 4 –2 0 –1 0 Very low Quality points deducted for sparse data and incomplete reporting of results. Directness point deducted for short follow-up (24 hours)
3 (618) Prevention of pressure ulcers Topical lotions and dressings versus placebo or other lotions and dressings 4 –2 0 –1 0 Very low Quality points deducted for incomplete reporting of results and poor follow-up. Directness point deducted for no intention-to-treat analysis
1 (52) Prevention of pressure ulcers Air-filled vinyl boot versus hospital pillow 4 –2 0 0 0 Low Quality points deducted for sparse data and incomplete reporting of results
1 (111) Prevention of pressure ulcers Hydrocellular heel supports versus orthopaedic wool padding/standard care 4 –2 0 0 0 Low Quality points deducted for sparse data and no intention-to-treat analysis
1 (98) Prevention of pressure ulcers Low-air-loss hydrotherapy beds versus other specialised support surfaces 4 –2 0 0 0 Low Quality points deducted for sparse data and weak methods
What are the effects of treatments in people with pressure ulcers?
3 (202) Healing rates Air-fluidised supports versus standard care 4 –1 0 –1 0 Low Quality point deducted for incomplete reporting of results. Directness point deducted for no intention-to-treat analysis
5 (372) Healing rates Alternating-pressure surfaces versus standard/other care 4 –2 0 0 0 Low Quality points deducted for incomplete reporting of results and poor study completion rate
at least 32 (at least 208) Healing rates Debridement versus no debridement or different debriding agents versus each other 4 –3 0 0 0 Very low Quality points deducted for incomplete reporting of results, weak methods, and poor trial completion
7 (at least 396) Healing rates Hydrocolloid dressings versus gauze soaked in saline, hypochlorite, or povidone iodine 4 –1 0 –1 0 Low Quality point deducted for weak methods. Directness point deducted for significance of meta-analysis result being sensitive to the method of calculation
15 (unclear) Healing rates Hydrocolloid dressings versus non-hydrocolloid dressings other than gauze soaked in saline, hypochlorite, or povidone iodine 4 –2 0 0 0 Low Quality points deducted for weak methods and incomplete reporting of results
6 (154) Healing rates Electrotherapy versus sham electrotherapy or standard treatment 4 –2 0 0 0 Low Quality points deducted for weak methods and incomplete reporting of results
4 (360) Healing rates Low-air-loss beds versus standard beds or standard care 4 –1 0 –1 0 Low Quality point deducted for incomplete reporting of results. Directness point deducted for no statistical analysis between groups for 2 analyses
2 (104) Healing rates Low-level laser treatment versus standard care or sham treatment 4 –2 0 0 0 Low Quality points deducted for sparse data and incomplete reporting of results
1 (120) Healing rates Low-tech constant-low-pressure supports versus each other 4 –2 0 0 0 Low Quality points deducted for sparse data and incomplete reporting of results
9 (400) Healing rates Nutritional supplements versus control 4 –2 0 –1 0 Very low Quality points deducted for weak methods and incomplete reporting of results. Directness point deducted for no intention-to-treat analysis in some trials
2 (235) Healing rates Seat cushions versus each other or standard care 4 –2 0 –1 0 Very low Quality points deducted for incomplete reporting of results and weak methods. Directness point deducted for no intention-to-treat analysis (selective exclusion of participants from analysis)
2 (128) Healing rates Ultrasound versus sham ultrasound 4 –3 0 0 0 Very low Quality points deducted for sparse data, weak methods, and incomplete reporting of results
1 (18) Healing rates Ultrasound plus ultraviolet light versus standard care or versus laser treatment 4 –3 0 0 0 Very low Quality points deducted for sparse data, weak methods, and small number of events (3 failures in total in trial)
2 (57) Healing rates Topical negative pressure versus control 4 –3 0 0 0 Very low Quality points deducted for sparse data, weak methods, and differences between groups at baseline
3 (159) Healing rates Topical phenytoin versus control/standard treatment 4 –2 –1 –1 0 Very low Quality points deducted for sparse data and weak methods. Consistency point deducted for conflicting results. Directness point deducted for baseline differences

We initially allocate 4 points to evidence from RCTs, and 2 points to evidence from observational studies. To attain the final GRADE score for a given comparison, points are deducted or added from this initial score based on preset criteria relating to the categories of quality, directness, consistency, and effect size. Quality: based on issues affecting methodological rigour (e.g., incomplete reporting of results, quasi-randomisation, sparse data [<200 people in the analysis]). Consistency: based on similarity of results across studies. Directness: based on generalisability of population or outcomes. Effect size: based on magnitude of effect as measured by statistics such as relative risk, odds ratio, or hazard ratio.

Glossary

Air-fluidised supports

Membranes that cover a layer of particles that are fluidised by having air forced through them. The airflow can be turned off, which makes the surface solid again, to allow the person to be moved. People find it difficult to get in and out of these beds independently; therefore, they are usually reserved for people who spend most of the day in bed.

Alternating-pressure surfaces

Mattresses or overlays made of one or two layers of parallel air sacs. Alternate sacs are inflated and deflated, which provides alternating pressure and release for each area of skin.

Dextranomer paste

Anhydrous, porous beads 0.1 mm to 0.3 mm in diameter. These beads are hydrophilic and absorb and adsorb exudate, wound debris, and bacteria, depending on particle size.

Electrotherapy

The application of electrical fields by placing electrodes near a wound. Treatments include pulsed electromagnetic therapy, low-intensity direct current, negative-polarity and positive-polarity electrotherapy, and alternating-polarity electrotherapy.

Low- or high-tech constant-low-pressure supports

Mattresses, overlays, and cushions made of high-density or contoured foam or filled with fibre, gel, water, beads, or air. They increase the area of contact between the person and the support surface and thus reduce the pressure at the interface. See also air-fluidised supports, low-air-loss beds, and low-air-loss hydrotherapy beds.

Low-air-loss beds

Mattresses that consist of inflatable upright sacs of semipermeable fabric. Inflation of the sacs increases the area of contact between the individual and the support surface and reduces the pressure on the skin. People find it difficult to get in and out of these beds independently; therefore, they are usually reserved for people who spend most of the day in bed.

Low-air-loss hydrotherapy beds

A mattress that consists of cushions covered by a permeable, fast-drying filter sheet, through which air is circulated. The bed also contains a urine-collecting device.

Low-quality evidence

Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.

Moderate-quality evidence

Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.

Therapeutic ultrasound

The application of ultrasound to a wound with a transducer and water-based gel. The power of ultrasound waves used in wound healing is low to avoid heating the tissues.

Topical negative pressure

Negative pressure (suction) applied to a wound through an open-cell dressing (e.g., foam or felt).

Very low-quality evidence

Any estimate of effect is very uncertain.

Disclaimer

The information contained in this publication is intended for medical professionals. Categories presented in Clinical Evidence indicate a judgement about the strength of the evidence available to our contributors prior to publication and the relevant importance of benefit and harms. We rely on our contributors to confirm the accuracy of the information presented and to adhere to describe accepted practices. Readers should be aware that professionals in the field may have different opinions. Because of this and regular advances in medical research we strongly recommend that readers' independently verify specified treatments and drugs including manufacturers' guidance. Also, the categories do not indicate whether a particular treatment is generally appropriate or whether it is suitable for a particular individual. Ultimately it is the readers' responsibility to make their own professional judgements, so to appropriately advise and treat their patients. To the fullest extent permitted by law, BMJ Publishing Group Limited and its editors are not responsible for any losses, injury or damage caused to any person or property (including under contract, by negligence, products liability or otherwise) whether they be direct or indirect, special, incidental or consequential, resulting from the application of the information in this publication.

References

  • 1.European Pressure Ulcer Advisory Panel (EPUAP). Guideline on treatment of pressure ulcers. Oxford: EPUAP, 1999. Available at http://www.epuap.org/gltreatment.html (last accessed 24 March 2011). [Google Scholar]
  • 2.Kaltenhaler E, Whitfield MD, Walters SJ, et al. UK, USA, and Canada: how do their pressure ulcer prevalence and incidence data compare? J Wound Care 2001;10:530–535. [DOI] [PubMed] [Google Scholar]
  • 3.Reed RL, Hepburn K, Adelson R, et al. Low serum albumin levels, confusion and faecal incontinence: are these risk factors for pressure ulcers in mobility-impaired hospitalised adults? Gerontology 2003;49:255–259. [DOI] [PubMed] [Google Scholar]
  • 4.Allman RM. Pressure ulcer prevalence, incidence, risk factors, and impact. Clin Geriatr Med 1997;13:421–436. [PubMed] [Google Scholar]
  • 5.Thomas DR, Goode PS, Tarquine PH, et al. Hospital acquired pressure ulcers and risk of death. J Am Geriatr Soc 1996;44:1435–1440. [DOI] [PubMed] [Google Scholar]
  • 6.Clough NP. The cost of pressure area management in an intensive care unit. J Wound Care 1994;3:33–35. [DOI] [PubMed] [Google Scholar]
  • 7.McInnes E, Cullum NA, Bell-Syer SE, et al. Support surfaces for pressure ulcer prevention. In: The Cochrane Library, Issue 2, 2010. Chichester, UK: John Wiley & Sons, Ltd. Search date 2008. 18843621 [Google Scholar]
  • 8.Reddy M, Gill SS, Rochon PA. Preventing pressure ulcers: a systematic review. JAMA 2006;296:974−984. [DOI] [PubMed] [Google Scholar]
  • 9.Theaker C, Kuper M, Soni N. Pressure ulcer prevention in intensive care – a randomised control trial of two pressure-relieving devices Anaesthesia 2005;60:395–399. [DOI] [PubMed] [Google Scholar]
  • 10.Nixon J, Nelson EA, Cranny G, et al. Pressure relieving support surfaces: a randomised evaluation. Health Technol Assess 2006;10:1–163. [DOI] [PubMed] [Google Scholar]
  • 11.Nixon J, Cranny G, Iglesias C, et al. Randomised, controlled trial of alternating pressure mattresses compared with alternating pressure overlays for the prevention of pressure ulcers: PRESSURE (pressure relieving support surfaces) trial. BMJ 2006;332:1413−1417. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 12.Iglesias C, Nixon J, Cranny G, et al. Pressure relieving support surfaces (PRESSURE) trial: Cost effectiveness analysis. BMJ 2006;332:1416−1418. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 13.Langer G, Schloemer G, Knerr A, et al. Nutritional interventions for preventing and treating pressure ulcers. In: The Cochrane Library, Issue 2, 2010. Chichester, UK: John Wiley & Sons, Ltd. Search date 2002. [Google Scholar]
  • 14.Ek AC, Unosson M, Larsson J, et al. The development and healing of pressure sores related to the nutritional state. Clin Nutr 1991;10:245−250. [DOI] [PubMed] [Google Scholar]
  • 15.Cullum N, Deeks JJ, Fletcher AW, et al. Preventing and treating pressure sores. Qual Health Care 1995;4:289–297. Search date 1995. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 16.Defloor T, De Bacquer D, Grypdonck MH. The effect of various combinations of turning and pressure reducing devices on the incidence of pressure ulcers. Int J Nurs Stud 2005;42:37–46. [DOI] [PubMed] [Google Scholar]
  • 17.Young T. The 30 degree tilt position vs the 90 degree lateral and supine positions in reducing the incidence of non-blanching erythema in a hospital inpatient population: a randomised controlled trial. J Tissue Viability 2004;14:88−86. [DOI] [PubMed] [Google Scholar]
  • 18.O'Meara SM, Cullum NA, Majid M, et al. Systematic review of antimicrobial agents used for chronic wounds. Br J Surg 2001;88:4–21. Search date 2000. [DOI] [PubMed] [Google Scholar]
  • 19.Torra i Bou JE, Segovia Gomez T, Verdu Soriano J, et al. The effectiveness of a hyperoxygenated fatty acid compound in preventing pressure ulcers. J Wound Care 2005;14:117–121. [DOI] [PubMed] [Google Scholar]
  • 20.Torra i Bou JE, Rueda Lopez J, Canames G, et al. Heel pressure ulcers. Comparative study between heel protective bandage and hydrocellular dressing with special form for the heel. Rev Enferm 2002;25:50–56. [in Spanish] [PubMed] [Google Scholar]
  • 21.Cullum N, Nelson EA, Flemming K, et al. Systematic reviews of wound care management: (5) beds; (6) compression; (7) laser therapy, therapeutic ultrasound, electrotherapy and electromagnetic therapy. Health Technol Assess 2001;5:1–221. Search date 2000. [DOI] [PubMed] [Google Scholar]
  • 22.Reddy M, Gill SS, Kalkar SR, et al. Treatment of pressure ulcers: a systematic review. JAMA 2008;300:2647–2662. [DOI] [PubMed] [Google Scholar]
  • 23.Bradley M, Cullum N, Sheldon T. The debridement of chronic wounds: a systematic review. Health Technol Assess 1999;3:1–78. Search date 1998. [PubMed] [Google Scholar]
  • 24.Bradley M, Cullum N, Nelson EA, et al. Systematic reviews of wound care management: (2). Dressings and topical agents used in the healing of chronic wounds. Health Technol Assess 1999;3:1–35. Search date 1997. [PubMed] [Google Scholar]
  • 25.Altman DG, Deeks JJ, Sackett DL. Odds ratios should be avoided when events are common. BMJ 1998;317:1318. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 26.Houghton PE, Campbell KE, Fraser CH, et al. Electrical stimulation therapy increases rate of healing of pressure ulcers in community-dwelling people with spinal cord injury. Arch Phys Med Rehabil 2010;91:669–678. [DOI] [PubMed] [Google Scholar]
  • 27.Gentzkow GD, Pollack SV, Kloth LC, et al. Improved healing of pressure ulcers using dermapulse, a new electrical stimulation device. Wounds 1991;3:158–170. [Google Scholar]
  • 28.Adunsky A, Ohry A. Decubitus direct current treatment (DDCT) of pressure ulcers: results of a randomized double-blinded placebo controlled study. Arch Gerentol Geriatr 2005;41:261–269. [DOI] [PubMed] [Google Scholar]
  • 29.Bennett RG, Baran PJ, DeVone L, et al. Low airloss hydrotherapy versus standard care for incontinent hospitalized patients. J Am Geriatr Soc 1998;46:569–576. [DOI] [PubMed] [Google Scholar]
  • 30.Cereda E, Gini A, Pedrolli C, et al. Disease-specific, versus standard, nutritional support for the treatment of pressure ulcers in institutionalized older adults: a randomized controlled trial. J Am Geriatr Soc 2009;57:1395–1402. [DOI] [PubMed] [Google Scholar]
  • 31.Desneves KJ, Todrovic BE, Cassar A, et al. Treatment with supplementary arginine, vitamin C and zinc in patients with pressure ulcers: a randomised controlled trial. Clin Nutr 2005;24:979–987. [DOI] [PubMed] [Google Scholar]
  • 32.Lee SK, Posthauer ME, Dorner B, et al. Pressure ulcer healing with a concentrated, fortified, collagen protein hydrolysate supplement: a randomized controlled trial. Advances Skin Wound Care 2006;19:92−96. [DOI] [PubMed] [Google Scholar]
  • 33.Rosenthal MJ, Felton RM, Natasi AE, et al. Healing of advanced pressure ulcers by a generic total contact seat: 2 randomized comparisons with low air loss bed treatments. Arch Phys Med Rehabil 2003;84:1733–1742. [DOI] [PubMed] [Google Scholar]
  • 34.Akbari Sari A, Flemming K, Cullum NA, et al. Therapeutic ultrasound for pressure ulcers. In: The Cochrane Library, Issue 2, 2010. Chichester, UK: John Wiley & Sons, Ltd. Search date 2008. [Google Scholar]
  • 35.Ubbink DT, Westerbros SJ, Evans D, et al. Topical negative pressure for treating chronic wounds. In: The Cochrane Library, Issue 2, 2010. Chichester, UK: John Wiley & Sons, Ltd. Search date 2007. [Google Scholar]
  • 36.Van Den Boogaard M, De Laat E, Spauwen P, et al. The effectiveness of topical negative pressure in the treatment of pressure ulcers: a literature review. Eur J Plast Surg 2008;31:1–7. [Google Scholar]
  • 37.Rhodes RS, Heyneman CA, Culbertson VL, et al. Topical phenytoin treatment of stage II decubitus ulcers in the elderly. Ann Pharmacother 2001;35:675–681. [DOI] [PubMed] [Google Scholar]
  • 38.Hollisaz MT, Khedmat H, Yari F. A randomized clinical trial comparing hydrocolloid, phenytoin and simple dressings for the treatment of pressure ulcers. BMC Dermatol 2005;4:18. [DOI] [PMC free article] [PubMed] [Google Scholar]
BMJ Clin Evid. 2011 May 5;2011:1901.

Foam alternatives versus standard foam mattresses to prevent pressure ulcers

Summary

Alternative foam mattresses (such as viscoelastic foam) reduce the incidence of pressure ulcers in people at risk compared with standard hospital foam mattresses, although we don't know which is the best alternative to use.

Benefits and harms

Foam alternatives versus standard hospital mattress:

We found two systematic reviews (search dates 2008 and 2006). The second systematic review did not report outcomes data for included RCTs or perform a meta-analysis. Instead, it gave a narrative summary of results. We have therefore reported meta-analysis results from the first review. Both reviews identified the same 6 RCTs (2117 people in hospital). Five RCTs identified by the reviews compared foam alternatives versus a standard hospital mattress, primarily in elderly people in orthopaedic hospital wards.

Prevention of pressure ulcers

Compared with standard hospital mattresses Foam alternatives seem to be more effective than standard hospital mattresses at preventing pressure ulcers in primarily elderly people in orthopaedic hospital wards (moderate-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Prevention of pressure ulcers

Systematic review
2016 people
5 RCTs in this analysis
Incidence of pressure ulcers 10 to 15 days
with foam alternative mattress
with standard hospital mattress
Absolute results not reported

RR 0.40
95% CI 0.21 to 0.74
Moderate effect size foam alternative mattress

Systematic review
101 people in the emergency department and after admission to hospital with hip fracture
Data from 1 RCT
Incidence of pressure ulcers 14 days
4/48 (8%) with foam mattress
8/53 (15%) with standard hospital mattress

Reported as not significant
P value not reported
Not significant

Adverse effects

No data from the following reference on this outcome.

Different foam alternatives versus each other:

We found two systematic reviews (search dates 2008 and 2006). The second systematic review did not report outcomes data for included RCTs or perform a meta-analysis. Instead, it gave a narrative summary of results. We have therefore reported meta-analysis results from the first review. The reviews identified 5 RCTs (795 people) that compared different foam alternatives. We report the data from one RCT below; however, the other RCTs were too small to detect a difference between the foam alternatives, because few people in the trials developed pressure ulcers.

Prevention of pressure ulcers

Foam alternatives compared with each other A foam and fibre replacement mattress consisting of 5 sections may be more effective than a 4-inch thick dimpled foam mattress at preventing pressure ulcers. However, we don't know how other foam alternatives compare in terms of effectiveness (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Pressure of ulcers

Systematic review
40 people
Data from 1 RCT
Development of pressure ulcers
with foam and fibre replacement mattress consisting of 5 sections
with 4-inch (10 cm) thick dimpled foam mattress
Absolute results not reported

RR 0.42
95% CI 0.18 to 0.96
NNT for 10 to 21 days' treatment: 3
95% CI 2 to 25
Moderate effect size foam and fibre replacement mattress consisting of 5 sections

Adverse effects

No data from the following reference on this outcome.

Further information on studies

None.

Comment

Most RCTs were small and of poor quality, and few performed the same comparison. Alternative foam mattresses consisted of foam of varying densities, often within the same mattress, and some were sculptured.

Substantive changes

Foam alternatives versus standard foam mattresses to prevent pressure ulcers Search updated for an already included systematic review. No new evidence added. Categorisation unchanged (Beneficial).

BMJ Clin Evid. 2011 May 5;2011:1901.

Pressure-relieving overlays on operating tables to prevent pressure ulcers

Summary

Pressure-relieving overlays on operating tables may reduce the risk of pressure ulcer development.

Benefits and harms

Pressure-relieving overlays on operating tables versus standard table alone:

We found two systematic reviews (search dates 2008 and 2006), which identified the same 5 RCTs. The second systematic review did not perform a meta-analysis. Instead, it gave a narrative summary of results. We have therefore reported meta-analysis results from the earlier review. The second review, which reported the RCTs narratively, concluded that mattress overlays on operating tables may decrease the incidence of postoperative pressure ulcers.

Prevention of pressure ulcers

Compared with standard table alone Pressure-relieving overlays on operating tables may be more effective than no overlays on operating tables at preventing pressure ulcers. However, results were inconsistent between RCTs using different types of overlays (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Prevention of pressure ulcers

Systematic review
368 people
2 RCTs in this analysis
Incidence of pressure ulcers
3/188 (2%) with alternating-pressure overlay 7 days post surgery
14/180 (8%) with gel pad during surgery, standard mattress 7 days post surgery

RR 0.21
95% CI 0.06 to 0.70
P = 0.01
Moderate effect size alternating-pressure overlay 7 days post surgery

Systematic review
416 people who had had elective major general, gynaecological, or vascular surgery
Data from 1 RCT
Incidence of postoperative pressure ulcers 8 days
22/205 (11%) with viscoelastic polymer pad
43/211 (20%) with standard table alone

RR 0.53
95% CI 0.33 to 0.85
P = 0.008
Small effect size viscoelastic polymer pad

Systematic review
413 people
Data from 1 RCT
Proportion of people with ulcers of grade 2 or worse
6/206 (3%) with experimental foam overlay
3/207 (1%) with standard table alone

Significance assessment not performed

Systematic review
175 people undergoing cardiac surgery
Data from 1 RCT
Proportion of people with grade 1 to 2 pressure ulcers
13/85 (15%) with thermoactive 4-cm viscoelastic foam overlay plus standard operating table
9/90 (10%) with standard operating table alone

RR 1.53
95% CI 0.69 to 3.39
P = 0.3
Small effect size thermoactive 4-cm viscoelastic foam overlay plus standard operating table

Adverse effects

No data from the following reference on this outcome.

Further information on studies

Some of the RCTs identified by the review were small and most were of poor quality; few performed the same comparison.

Comment

None.

Substantive changes

Pressure-relieving overlays on operating tables to prevent pressure ulcers Search updated for an already included systematic review. New evidence added. Categorisation changed from Unknown effectiveness to Likely to be beneficial.

BMJ Clin Evid. 2011 May 5;2011:1901.

Low-air-loss beds to prevent pressure ulcers

Summary

Low-air-loss beds may reduce the risk of pressure ulcers compared with standard intensive-care beds.

Benefits and harms

Low-air-loss beds versus standard intensive-care beds/alternating-pressure mattresses:

We found two systematic reviews (search dates 2008 and 2006). The second systematic review did not report outcomes data for included RCTs or perform a meta-analysis. Instead, it gave a narrative summary of results. We have therefore reported results from the first review and have reported the further RCT identified by the second review separately.

Prevention of pressure ulcers

Compared with standard intensive-care beds/alternating-pressure mattresses Low-air-loss beds in intensive care may be more effective than standard intensive-care beds at preventing pressure ulcers, but we don't know whether they are more effective than alternating-pressure mattresses (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Prevention of pressure ulcers

Systematic review
98 people with expected intensive care unit stay of >3 days
Data from 1 RCT
Risk of new pressure ulcers
6/49 (12%) with low-air-loss beds in intensive care
25/49 (51%) with standard intensive-care beds

RR 0.24
95% CI 0.11 to 0.53
The review reported that the intensive-care bed was poorly described, allocation concealment was unclear, and outcome assessment was not blinded
Moderate effect size low-air-loss beds

Systematic review
221 people
2 RCTs in this analysis
Risk of pressure ulcers 40 days
12/111 (11%) with low-air-loss beds
37/110 (34%) with static air overlay

RR 0.33
95% CI 0.16 to 0.67
P = 0.002
Moderate effect size low-air-loss beds

RCT
62 people in intensive care
In review
Development of pressure ulcers
3/30 (10%) with low-air-loss beds
6/32 (19%) with alternating-pressure mattresses

P = 0.35
The RCT may have been underpowered to detect a clinically important difference between groups
Not significant

Adverse effects

No data from the following reference on this outcome.

Further information on studies

None.

Comment

None.

Substantive changes

Low-air-loss beds to prevent pressure ulcers Search updated for an already included systematic review. New evidence added. Categorisation unchanged (Likely to be beneficial). However, all RCTs conducted in an intensive care setting, which may limit generalisability of results.

BMJ Clin Evid. 2011 May 5;2011:1901.

Medical sheepskin overlays to prevent pressure ulcers

Summary

Medical sheepskin overlays may reduce the risk of pressure ulcers compared with standard care.

Benefits and harms

Medical sheep skin overlays versus standard care:

We found two systematic reviews (search dates 2008 and 2006). The second systematic review did not report outcomes data for included RCTs or perform a meta-analysis. Instead, it gave a narrative summary of results. We have therefore reported results from the first review.

Prevention of pressure ulcers

Compared with standard care Medical sheepskin overlays plus standard care seem more effective than standard care alone at preventing pressure ulcers (moderate-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Prevention of pressure ulcers

Systematic review
730 people over 18 years of age
2 RCTs in this analysis
Occurrence of pressure ulcers
35/373 (9%) with medical sheepskin overlay with or without usual care
80/365 (22%) with standard hospital mattress/usual care

RR 0.42
95% CI 0.22 to 0.81
P = 0.009
Moderate effect size medical sheepskin overlay with or without usual care

Adverse effects

No data from the following reference on this outcome.

Further information on studies

None.

Comment

None.

Substantive changes

Medical sheepskin overlays to prevent pressure ulcers Search updated for an already included systematic review. New evidence added. Categorisation unchanged (Likely to be beneficial).

BMJ Clin Evid. 2011 May 5;2011:1901.

Alternating-pressure surfaces to prevent pressure ulcers

Summary

We don't know if alternating-pressure surfaces are effective for preventing pressure ulcers.

Benefits and harms

Alternating-pressure surfaces versus standard foam mattress:

We found two systematic reviews (search date 2008, 11 RCTs;and 2006) comparing alternating-pressure surfaces versus standard foam mattrress. The second systematic review did not report outcomes data for included RCTs or perform a meta-analysis. Instead, it gave a narrative summary of results. We have therefore reported meta-analysis results from the first review. The first review reported that most RCTs on alternating pressure did not adequately describe the equipment being evaluated, including the size of the air cells and cycle time, which may be important in determining effectiveness.

Prevention of pressure ulcers

Compared with standard foam mattress Alternating-pressure surfaces may be more effective than standard foam mattresses at preventing pressure ulcers. However, evidence was very weak (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Prevention of pressure ulcers

Systematic review
409 people
2 RCTs in this analysis
Pressure ulcer development
13/221 (6%) with alternating-pressure surfaces
31/188 (16%) with standard foam mattress

RR 0.31
95% CI 0.17 to 0.58
P = 0.0002
The first RCT included in the analysis gave no indication of whether allocation concealment or blinded outcome assessment had been used, and in the second RCT, the denominators were numbers presented by the trial after withdrawals and attrition, and the analysis was not by intention to treat
Moderate effect size alternating-pressure surfaces

Adverse effects

No data from the following reference on this outcome.

Alternating-pressure surfaces versus constant-low-pressure supports:

We found two systematic reviews (search date 2008, 11 RCTs;and 2006) comparing alternating-pressure surfaces versus constant-low-pressure supports. The second systematic review did not report outcomes data for included RCTs or perform a meta-analysis. Instead, it gave a narrative summary of results. We have therefore reported meta-analysis results from the first review. The first review reported that most RCTs on alternating pressure did not adequately describe the equipment being evaluated, including the size of the air cells and cycle time, which may be important in determining effectiveness.

Prevention of pressure ulcers

Compared with constant-low-pressure supports We don't know whether alternating-pressure surfaces are more effective than constant-low-pressure supports at preventing pressure ulcers (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Prevention of pressure ulcers

Systematic review
1606 people
10 RCTs in this analysis
Rate of pressure ulcer formation
with alternating-pressure surfaces
with constant-low-pressure supports
Absolute results not reported

RR 0.85
95% CI 0.64 to 1.13
P = 0.28
The meta-analysis pooled trials of several different types of surface and remains underpowered (the wide confidence intervals do not exclude a clinically important treatment effect). The review emphasised that many of the RCTs were small. It reported that further trials are needed to determine whether alternating-pressure devices and constant-low-pressure devices are associated with a clinically important difference in the risk of pressure ulceration
Not significant

Adverse effects

No data from the following reference on this outcome.

Alternating-pressure surfaces versus each other:

We found two systematic reviews (search date 2008, 11 RCTs; and 2006) comparing alternating-pressure surfaces versus each other. The second systematic review did not report outcomes data for included RCTs or perform a meta-analysis. Instead, it gave a narrative summary of results. We have therefore reported meta-analysis results from the first review. The first review reported that most RCTs on alternating pressure did not adequately describe the equipment being evaluated, including the size of the air cells and cycle time, which may be important in determining effectiveness.

Prevention of pressure ulcers

Compared with each other We don't know whether one alternating-pressure surface is consistently more effective than any other (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Prevention of pressure ulcers

RCT
1972 acute and elective inpatients at least 55 years old admitted to vascular, orthopaedic, medical, or care-of-the-elderly wards
In review
Proportion of people developing new pressure ulcers of grade 2 or above
101/982 (10%) with alternating-pressure mattresses
106/989 (11%) with alternating-pressure mattress overlays

RR 1.04
95% CI 0.81 to 1.35
Not significant

Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects

RCT
1972 acute and elective inpatients at least 55 years old admitted to vascular, orthopaedic, medical, or care-of-the-elderly wards
In review
Proportion of people who were dissatisfied
186/982 (19%) with alternating-pressure mattresses
230/990 (23%) with alternating-pressure mattress overlays

Mean difference 4.4%
95% CI 0.7% to 7.9%
P = 0.02
Effect size not calculated alternating-pressure mattresses

Further information on studies

A cost-effectiveness assessment of the trial found no significant difference between alternating-pressure mattresses and overlays in mean time to development of an ulcer or hospital stay, although people using pressure mattresses took longer to develop an ulcer, and stayed in hospital for less time than people using overlays (development of an ulcer: mean difference 11 days, 95% CI –24 days to +4 days; hospital stay: 19 days with mattress v 20 days with overlays; reported as not significant; CI not reported; absolute numbers not reported for either outcome).

Most RCTs were small and of poor quality, and few performed the same comparison.Three small RCTs (181 people) identified by the first review compared different alternating-pressure devices versus each other; none found a significant difference (RR values all not significant), although all three RCTs were underpowered.

Comment

None.

Substantive changes

Alternating-pressure surfaces to prevent pressure ulcers Search updated for an already included systematic review. New evidence added. Categorisation unchanged (Unknown effectiveness), as there remains insufficient evidence to judge the effects of this intervention.

BMJ Clin Evid. 2011 May 5;2011:1901.

Seat cushions to prevent pressure ulcers

Summary

We don't know if seat cushions are effective for preventing pressure ulcers.

Benefits and harms

Seat cushions versus each other:

We found two systematic reviews (search dates 2008and 2006). The second systematic review did not report outcomes data for included RCTs or perform a meta-analysis. Instead, it gave a narrative summary of results. We have therefore reported results from the earlier review.

Prevention of pressure ulcers

Compared with each other We don't know whether any one seat cushion is consistently more effective than the others at preventing pressure ulcers (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Prevention of pressure ulcers

Systematic review
52 people
Data from 1 RCT
Incidence of pressure ulcers 5 months
with slab-foam cushions
with bespoke contoured foam cushions
Absolute results not reported

RR 1.06
95% CI 0.75 to 1.49
The confidence intervals of the RCTs included in the review suggest that they were probably underpowered to detect a clinically important difference between different cushions. 3 of the RCTs were of poor methodological quality (unclear method of randomisation/allocation concealment)
Not significant

Systematic review
141 people
Data from 1 RCT
Incidence of pressure ulcers 3 months
with gel-and-foam wheelchair cushion
with foam cushion
Absolute results not reported

RR 0.61
95% CI 0.37 to 1.00
Not significant

Systematic review
248 people
Data from 1 RCT
Incidence of pressure ulcers 3 months
with slab-foam cushions
with contoured foam cushion
Absolute results not reported

RR 1.00
95% CI 0.84 to 1.18
Not significant

Systematic review
32 people using wheelchairs
Data from 1 RCT
Incidence of pressure ulcers
with pressure-reducing seat cushion
with foam cushions (3-inch convoluted [eggcrate] foam)
Absolute results not reported

RR 0.68
95% CI 0.33 to 1.42
Not significant

Adverse effects

No data from the following reference on this outcome.

Further information on studies

None.

Comment

None.

Substantive changes

Seat cushions to prevent pressure ulcers Search updated for an already included systematic review. New evidence added. Categorisation unchanged (Unknown effectiveness), as there remains insufficient evidence to judge the effects of this intervention.

BMJ Clin Evid. 2011 May 5;2011:1901.

Electric profiling beds to prevent pressure ulcers

Summary

We don't know if electric profiling beds are effective for preventing pressure ulcers.

Benefits and harms

Electric profiling beds to prevent pressure ulcers versus standard hospital beds:

We found two systematic reviews (search dates 2008and 2006). The second systematic review did not report outcomes data for included RCTs or perform a meta-analysis. Instead, it gave a narrative summary of results. Both reviews reported the same RCT; therefore, we have reported results from the earlier review.

Prevention of pressure ulcers

Compared with standard hospital beds We don't know whether an electric profiling bed plus a pressure-relieving foam mattress is more effective than a standard hospital bed plus a pressure-relieving foam or alternating-pressure mattress at preventing pressure ulcers (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Prevention of pressure ulcers

Systematic review
70 people in medical or surgical hospital wards
Data from 1 RCT
Incidence of pressure ulcers 10 days
0 with electrically operated profiling bed
0 with standard hospital bed

Reported as not significant
P value not reported
The low event rate means that the RCT was underpowered to detect a clinically important difference between groups
Not significant

Adverse effects

No data from the following reference on this outcome.

Further information on studies

None.

Comment

None.

Substantive changes

Electric profiling beds to prevent pressure ulcers Search updated for an already included systematic review. No new evidence added. Categorisation unchanged (Unknown effectiveness), as there remains insufficient evidence to judge the effects of this intervention.

BMJ Clin Evid. 2011 May 5;2011:1901.

Low-tech constant-low-pressure supports to prevent pressure ulcers

Summary

We don't know if low-tech constant-low-pressure supports are effective for preventing pressure ulcers.

Benefits and harms

Low-tech constant-low-pressure supports versus each other:

We found two systematic reviews (search dates 2008 and 2006). The reviews identified 11 RCTs about the effects of low-tech constant-low-pressure supports in preventing pressure ulcers, which were underpowered (because few people in the trial developed pressure ulcers and there was a probability of small differences between surfaces that work in similar ways), or too flawed to produce reliable conclusions. The first review did not perform a meta-analysis because of heterogeneity among the trials in types of support and comparisons assessed, and the second review was narrative in character.

Adverse effects

No data from the following reference on this outcome.

Further information on studies

Most RCTs were small and of poor quality, and few performed the same comparison.

Comment

None.

Substantive changes

Low-tech constant-low-pressure supports to prevent pressure ulcers Search updated for an already included systematic review. New evidence added. Categorisation unchanged (Unknown effectiveness), as there remains insufficient evidence to judge the effects of this intervention.

BMJ Clin Evid. 2011 May 5;2011:1901.

Nutritional supplements to prevent pressure ulcers

Summary

We don't know whether pressure ulcers can be prevented by use of nutritional interventions.

Benefits and harms

Nutritional supplements versus control:

We found two systematic reviews (search dates 2002 and 2006) assessing parenteral and enteral nutritional supplements. The second systematic review did not report outcomes data for included RCTs or perform a meta-analysis. Instead, it gave a narrative summary of results. We have therefore reported results from the earlier review, and have reported the further RCT identified by the second review separately.

Prevention of pressure ulcers

Compared with control or standard care We don't know whether nutritional supplements are effective at preventing pressure ulcers (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Prevention of pressure ulcers

Systematic review
672 people acutely ill people aged >5 years
Data from 1 RCT
Prevention of pressure ulcers 15 days
118/295 (40%) with nutritional supplements
181/377 (48%) with control

RR 0.83
95% CI 0.70 to 0.99
Small effect size nutritional supplements

Systematic review
59 people
Data from 1 RCT
Prevention of pressure ulcers 6 months
with nutritional supplements
with control
Absolute results not reported

RR 0.22
95% CI 0.01 to 4.28
The RCT was too small to detect a clinically important difference
Not significant

Systematic review
140 people
Data from 1 RCT
Prevention of pressure ulcers 2 weeks
with nutritional supplements
with control
Absolute results not reported

RR 0.92
95% CI 0.64 to 1.32
The RCT was too small to detect a clinically important difference
Not significant

Systematic review
103 people
Data from 1 RCT
Prevention of pressure ulcers 28 days
with nutritional supplements
with control
Absolute results not reported

RR 0.92
95% CI 0.65 to 1.30
The RCT was too small to detect a clinically important difference
Not significant

RCT
501 people newly admitted to long-term care; mean age 80.1 years
In review
Prevention of pressure ulcers 182 days
10% with oral nutritional supplements
12% with control
Absolute numbers not reported

P value not reported

Adverse effects

No data from the following reference on this outcome.

Further information on studies

Most of the RCTs in the reviews had weak methods. Flaws included lack of information about the method of randomisation, lack of blinding of outcome assessment, high withdrawal rates, and lack of intention-to-treat analyses.

Comment

None.

Substantive changes

No new evidence

BMJ Clin Evid. 2011 May 5;2011:1901.

Repositioning (including regular "turning") to prevent pressure ulcers

Summary

We don't know if repositioning (regular turning) is effective for preventing pressure ulcers.

Benefits and harms

Repositioning versus control, usually standard care:

We found two systematic reviews (search dates 1995 and 2006). The second systematic review did not report outcomes data for included RCTs or perform a meta-analysis, but instead gave a narrative summary of results. We have therefore reported results from the earlier review, and have reported a further RCT identified by the second review separately.

Prevention of pressure ulcers

Compared with standard care We don't know whether any specific repositioning regimen is more effective than standard care alone at preventing pressure ulcers (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Prevention of pressure ulcers

Systematic review
217 people
3 RCTs in this analysis
Incidence of pressure ulcers
with manual repositioning
with control
Absolute results not reported

Reported as not significant
P value not reported
The review reported that the RCTs were all too small and weak to detect clinically important differences between treatments
Not significant

RCT
5-armed trial
838 people with Braden scores <17
In review
Development of pressure ulcers 4 weeks
14% with turning every 2 hours on a standard mattress
24% with turning every 3 hours on a standard mattress
3% with turning every 4 hours on a viscoelastic foam mattress
16% with turning every 6 hours on a viscoelastic foam mattress
20% with standard care

4-hour turning v standard care: OR 0.12, 95% CI 0.03 to 0.48
4-hour turning v other regimens: reported as significant; P value not reported
Other turning regimens v standard care: P >0.05
Large effect size turning every 4 hours on a viscoelastic foam mattress

Adverse effects

No data from the following reference on this outcome.

Repositioning at 30 degree tilt versus a 90 degree lateral and supine position:

We found two systematic reviews (search dates 1995 and 2006). The second systematic review did not report outcomes data for included RCTs or perform a meta-analysis, but instead gave a narrative summary of results. We have therefore reported results from the earlier review, and have reported further RCTs identified by the second review separately.

Prevention of pressure ulcers

Repositioning at 30 degree tilt versus a 90 degree lateral and supine position We don't know whether repositioning at 30 degree tilt is more effective than a 90 degree lateral and supine position at preventing pressure ulcers at 24 hours in hospitalised elderly people (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Prevention of pressure ulcers

RCT
46 hospitalised elderly people
In review
Non-blanching erythema 24 hours
3/23 (13%) with 30° tilt position
2/23 (9%) with 90° lateral and supine position

P >0.05
Not significant

RCT
46 hospitalised elderly people
In review
Visible breaks in the epidermis 24 hours
0/23 (0%) with 30° tilt position
0/23 (0%) with 90° lateral and supine position

Reported as non-significant
P value and significance not reported
Not significant

RCT
46 hospitalised elderly people
In review
Proportion of people who found the position difficult to maintain
20/23 (87%) with 30° tilt position
5/23 (22%) with 90° lateral and supine position

P <0.05
Effect size not calculated 90° lateral and supine position

No data from the following reference on this outcome.

Adverse effects

No data from the following reference on this outcome.

Further information on studies

None.

Comment

The three RCTs identified by the first review were small, of poor quality, and no comparisons were undertaken more than once. In one of the RCTs of regular repositioning identified by the review, 23 people were randomised to repositioning, but only 10 people actually were repositioned regularly. The first RCT identified by the second review cluster-randomised hospital wards to each turning regimen. Within each ward, 5 people were randomly selected for the intervention, and the remainder were allocated to standard care.

Substantive changes

No new evidence

BMJ Clin Evid. 2011 May 5;2011:1901.

Topical lotions and dressings to prevent pressure ulcers

Summary

We don't know if topical lotions and dressings are effective for preventing pressure ulcers.

Benefits and harms

Topical lotions and dressings versus placebo or other lotions and dressings:

We found two systematic reviews (search date 2000, 2 RCTs; and 2006, 3 RCTs). The second systematic review did not report outcomes data for included RCTs or perform a meta-analysis. Instead, it gave a narrative summary of results. We have therefore reported results from the earlier review, and have reported further RCTs identified by the second review individually. The first review identified no RCTs assessing dressings for pressure ulcer prevention.

Prevention of pressure ulcers

Compared with placebo/other lotions We don't know whether any specific topical lotion or dressing is more effective than any other specific topical lotion or dressing at preventing pressure ulcers (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Prevention of pressure ulcers

Systematic review
319 people
Data from 1 RCT
Incidence of new pressure ulcers 3 weeks
with hexachlorophene (hexachlorophane) lotion
with cetrimide lotion
Absolute results not reported

OR 0.87
95% CI 0.46 to 1.65
These results must be interpreted with caution, as they were based on a completer analysis of 167 people
Not significant

Systematic review
120 people
Data from 1 RCT
Changes in skin condition 3 weeks
with hexachlorophene lotion
with inert lotion
Absolute results not reported

Reported as not significant
P value not reported
Not significant

RCT
380 people
In review
Proportion of people who developed pressure ulcers
12/164 (7%) with twice-daily topical application of a compound of 8 hyperoxygenated fatty acids
29/167 (17%) with placebo compound

RR 0.42
95% CI 0.22 to 0.80
Completer analysis; 13% of those randomised were not included in the analysis so results must be viewed with caution
Moderate effect size fatty acids

Adverse effects

No data from the following reference on this outcome.

Further information on studies

None.

Comment

None.

Substantive changes

No new evidence

BMJ Clin Evid. 2011 May 5;2011:1901.

Air-filled vinyl boots to prevent pressure ulcers

Summary

Air-filled vinyl boots with foot cradles may increase the risk of ulcers compared with other pressure-relieving surfaces.

Benefits and harms

Air-filled vinyl boot versus hospital pillow:

We found two systematic reviews (search date 2008 and 2006). The second systematic review did not report outcomes data for included RCTs or perform a meta-analysis, but instead gave a narrative summary of results. Both reviews reported the same RCT; therefore, we have reported results from the first review.

Prevention of pressure ulcers

Compared with hospital pillows An air-filled vinyl boot with built-in foot cradle may be less effective than hospital pillows at preventing pressure ulcers (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Prevention of pressure ulcers

Systematic review
52 people
Data from 1 RCT
Mean time to skin breakdown
10 days with vinyl boot
13 days with pillow

P <0.036
Effect size not calculated pillow

Systematic review
52 people
Data from 1 RCT
Development of heel ulcers
6 ulcers with vinyl boot
2 ulcers with pillow

Reported as not significant
P value not reported
Not significant

Adverse effects

No data from the following reference on this outcome.

Further information on studies

None.

Comment

The first review also identified one further RCT, which compared a bunny boot (fleece) high cushion heel protector, an egg crate (holds the foot suspended above the bed surface with heel through a window) heel lift positioner, and a foot waffle (felt-coated inflatable plastic pillow that encircles the foot) air cushion. The RCT found no significant differences between the devices in terms of pressure ulcer incidence. However, the review reported that it was unclear whether the number of incident ulcers or the number of participants with incident ulcers were being reported, only 240/338 (71%) people had follow-up data (53 people excluded who did not wear devices for 48 hours, 45 people excluded who were non-compliant), analysis was not by intention to treat, and there was a baseline difference between groups in sex.

Substantive changes

Air-filled vinyl boots to prevent pressure ulcers Search updated for an already included systematic review. New evidence added. Categorisation unchanged (Unlikely to be beneficial).

BMJ Clin Evid. 2011 May 5;2011:1901.

Hydrocellular heel supports to prevent pressure ulcers

Summary

Hydrocellular heel supports may decrease the risk of pressure ulcers compared with orthopaedic wool padding.

Benefits and harms

Hydrocellular heel supports versus orthopaedic wool padding/standard care:

We found one systematic review (search date 2006), which identified one RCT comparing the use of hydrocellular heel supports versus orthopaedic wool padding to prevent heel pressure ulcers.

Prevention of pressure ulcers

Compared with orthopaedic wool padding or standard care Hydrocellular heel supports may be more effective than orthopaedic wool padding at preventing heel pressure ulcers at 8 weeks, but we don't know whether they are more effective than other standard interventions (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Prevention of pressure ulcers

RCT
130 people
In review
Incidence of pressure ulcers 8 weeks
2/61 (3%) with hydrocellular heel supports
22/50 (44%) with orthopaedic wool padding

RR 0.07
95% CI 0.02 to 0.30
These results should be interpreted with caution because of the lack of intention-to-treat analysis
Large effect size hydrocellular heel supports

Adverse effects

No data from the following reference on this outcome.

Further information on studies

None.

Comment

None.

Substantive changes

No new evidence

BMJ Clin Evid. 2011 May 5;2011:1901.

Low-air-loss hydrotherapy beds to prevent pressure ulcers

Summary

Low-air-loss hydrotherapy beds may increase the risk of ulcers compared with other pressure-relieving surfaces.

Benefits and harms

Low-air-loss hydrotherapy beds versus other specialised support surfaces:

We found two systematic reviews (search dates 2008 and 2006). The second systematic review did not report outcomes data for included RCTs or perform a meta-analysis. Instead, it gave a narrative summary of results. Both reviews have reported the same RCT; therefore, we have reported results from the first review.

Prevention of pressure ulcers

Compared with other specialised support surfaces We don't know whether low-air-loss hydrotherapy beds and a range of support surfaces differ in effectiveness at reducing the proportion of people with grade 2 to 4 pressure ulcers at 60 days in people with incontinence on acute and long-stay wards, as differences between groups were not significant. However, more people developed ulcers with low-air-loss hydrotherapy beds (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Prevention of pressure ulcers

Systematic review
98 people with incontinence, admitted to acute and long-stay hospital wards
Data from 1 RCT
Development of pressure ulcers (grade 2 to 4) 60 days
8/42 (19%) with low-air-loss hydrotherapy beds
4/56 (7%) with support surfaces

RR 2.67
95% CI 0.86 to 8.37
The RCT is likely to have been underpowered to detect a clinically important difference between groups
Not significant

Adverse effects

No data from the following reference on this outcome.

Further information on studies

None.

Comment

None.

Substantive changes

Low-air-loss hydrotherapy beds to prevent pressure ulcers Search updated for an already included systematic review. No new evidence added. Existing evidence reassessed. Categorisation changed from Unlikely to be beneficial to Unknown effectiveness, as there remains insufficient evidence to judge the effects of this intervention.

BMJ Clin Evid. 2011 May 5;2011:1901.

Air-fluidised support to treat pressure ulcers

Summary

In people with pressure ulcers, air-fluidised supports may improve healing compared with standard care, although they can make it harder for people to get in and out of bed independently.

Benefits and harms

Air-fluidised supports versus standard care:

We found two systematic reviews. The first systematic review (search date 2000, 3 RCTs, 202 people) compared air-fluidised supports versus standard care. The second systematic review (search date 2008), which had different inclusion criteria, included one RCT identified by the first review (the first RCT reported above) and included further detail.

Healing rates

Compared with standard care Air-fluidised supports may be more effective than standard care (alternating-pressure mattresses, regular changes of position, sheepskin, gel pads, or limb protectors) at healing established pressure ulcers after a mean of 15 days in people in hospital, although we don't know about in people being cared for at home (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Healing rates

Systematic review
Number of participants unclear (see further information on studies)
Data from 1 RCT
Median change in total ulcer surface area mean 15 days
–1.2 cm2 with air-fluidised supports
+0.5 cm2 with standard care

Reported as significant
P value not reported
Effect size not calculated air-fluidised supports

Systematic review
Number of participants unclear (see further information on studies)
Data from 1 RCT
Median change in total ulcer surface area mean 15 days
with air-fluidised support
with standard care
Absolute results not reported

P = 0.05
Effect size not calculated air-fluidised support

Systematic review
97 people being cared for at home
Data from 1 RCT
Median change in total ulcer surface area 36 weeks
with air-fluidised support
with standard care
Absolute results not reported

Reported as not significant
P value not reported
This RCT had a 13% withdrawal rate and did not perform an intention-to-treat analysis
Not significant

Systematic review
72 people, 65 people completed study, aged >18 years, acute care, grade I to IV ulcers Median change in wound surface area
–1.2 cm2 with air-fluidised mattress
+0.5 cm2 with alternating-pressure mattress covered in foam

95% CI for difference –9.2 cm2 to –0.6 cm2
P = 0.01
Effect size not calculated air-fluidised mattress

Adverse effects

No data from the following reference on this outcome.

Further information on studies

The two RCTs reported from the systematic review had a combined population of 105 people; information about the population of the individual RCTs was not reported.

Comment

People are unable to move in and out of bed independently when they use air-fluidised beds, and this limits the number of people for whom they are suitable.

Substantive changes

Air-fluidised support to treat pressure ulcers New evidence added. Categorisation unchanged (Likely to be beneficial).

BMJ Clin Evid. 2011 May 5;2011:1901.

Alternating-pressure surfaces to treat pressure ulcers

Summary

We don't know whether healing is improved in people with pressure ulcers by use of alternating-pressure surfaces.

Benefits and harms

Alternating-pressure surfaces versus standard/other care:

We found one systematic review (search date 2008), which found 5 RCTs. The review did not pool data.

Healing rates

Compared with each other/standard care We don't know whether alternating-pressure surfaces are more effective than standard care at healing pressure ulcers, or whether any one alternating-pressure surface is consistently more effective than all the others (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Healing rates

Systematic review
199 people, 158 people completed study, mean age 80 years, acute care, grade I to IV ulcers
Data from 1 RCT
Wound surface area ulcer progress
72% with alternating-pressure mattress
75% with fluid mattress overlay
Absolute numbers not reported

P = 0.76
Not significant

Systematic review
113 people completed study, 55 years or over, acute care, grade II ulcers
Data from 1 RCT
Complete wound healing
10.3% with one type of alternating-pressure mattress
10.7% with another type of alternating-pressure overlay
Absolute numbers not reported

P = 0.75
Not significant

Systematic review
32 people completed study, aged 65 years or over, acute and long-term care, grade II or III ulcers
Data from 1 RCT
Reduction in median wound surface area per day
0.12 cm with one type of alternating-pressure mattress
0.08 cm with another type of alternating-pressure mattress

P = 0.57
Not significant

Systematic review
17 people, age range 66 to 99 years, acute and long-term care, grade II to IV ulcers
Data from 1 RCT
Wound surface area
with one type of alternating-pressure mattress
with another type of alternating-pressure mattress or overlay
Absolute results not reported

Reported as no significant difference in healing sores
P value not reported
Not significant

Systematic review
183 people, 112 completed study, age described as elderly, acute care, grade II to IV ulcers Complete heel ulcer healing
with one type of alternating-pressure mattress plus cushion
with another type of alternating-pressure mattress plus cushion
Absolute results not reported

P = 0.02
Effect size not calculated alternating-pressure mattress plus cushion

Adverse effects

No data from the following reference on this outcome.

Further information on studies

None.

Comment

People often have difficulty moving in bed independently on alternating-pressure mattresses.

Substantive changes

Alternating-pressure surfaces to treat pressure ulcers New evidence added. Categorisation unchanged (Unknown effectiveness), as there remains insufficient evidence to judge the effects of this intervention.

BMJ Clin Evid. 2011 May 5;2011:1901.

Debridement to treat pressure ulcers

Summary

We found no clinically important results from RCTs about the effects of debridement compared with no debridement in the treatment of people with pressure ulcers.

Benefits and harms

Debridement versus no debridement or different debriding agents versus each other:

We found two systematic reviews (search dates 1998 and 2008), which did not pool data.The first systematic review found no RCTs comparing debridement versus no debridement. It identified 32 RCTs comparing different debriding agents such as dextranomer paste, but the studies were small, included a range of wounds, and few comparisons were undertaken in more than one RCT. The review concluded that there was insufficient evidence to promote the use of any particular debriding agent over another. The second systematic review categorised dressings by their primary purpose (e.g., debriding, hydrating, etc.) and only included RCTs that calculated wound size, used evaluation tools that incorporated these measurements, or used complete wound healing as end points.

Healing rates

Debriding agents compared with each other We don't know whether any one debriding agent is consistently more effective than the other debriding agents at healing pressure ulcers (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Healing rates

Systematic review
28 people (26 people completed the study)
Data from 1 RCT
Reduction in wound surface
with collagenase
with papain-urea-chlorophyllin copper
Absolute results not reported

Reported as not significant
P value not reported
Not significant

Systematic review
135 people (78 people completed the study)
Data from 1 RCT
Reduction in wound surface
with collagenase
with fibrinolysin or deoxyribonuclease
Absolute results not reported

P = 0.12
Not significant

Systematic review
102 people (63 people completed the study)
Data from 1 RCT
Reduction in wound surface
with collagenase daily
with collagenase every 2 days
Absolute results not reported

P = 0.64
Not significant

Adverse effects

No data from the following reference on this outcome.

Further information on studies

The review also found further RCTs comparing debriding agents versus a variety of agents (including hydrating agents, absorbent agents, moist saline gauze, and sugar and egg white). Overall, the review concluded that no debriding agent was consistently superior to other dressings for wound healing.

Comment

None.

Substantive changes

Debridement to treat pressure ulcers New evidence added. Categorisation unchanged (Unknown effectiveness), as there remains insufficient evidence to judge the effects of this intervention.

BMJ Clin Evid. 2011 May 5;2011:1901.

Dressings (hydrocolloid and non-hydrocolloid) versus each other to treat pressure ulcers

Summary

We don't know which type of dressing is better for treating pressure ulcers.

Benefits and harms

Hydrocolloid dressings versus gauze soaked in saline, hypochlorite, or povidone iodine:

We found two systematic reviews (search dates 1997 and 2008) assessing dressings or topical agents for pressure ulcers. The second review did not pool data. It found 7 RCTs (32–94 people; 2 RCTs included in the first review) comparing hydrocolloid dressings versus moist saline gauze (6 RCTs) or moist povidone-iodine gauze (1 RCT). Of the 7 RCTs, 4 RCTs found no significant difference between groups in wound healing. One RCT (94 people) with weak methods did not report a statistical analysis between groups. Two RCTs (first RCT: 83 people; second RCT: 32 people [12 people completed]) found a significant benefit with hydrocolloid versus moist saline gauze. One of these RCTs (32 people) had weak methods (CLEAR NPT criteria [maximum 6]: RCT score 1). The remaining RCT had baseline differences between groups in ulcer size. Although these differences were not statistically significant, they may have biased the results against standard dressings.

Healing rates

Hydrocolloid dressings compared with gauze soaked in saline, hypochlorite, or povidone iodine We don't know whether hydrocolloid dressings are more effective at healing pressure ulcers (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Healing rates

Systematic review
396 people
5 RCTs in this analysis
Healing rate up to 75 days
102/205 (50%) with hydrocolloid dressings
59/191 (31%) with standard dressings

OR 2.57
95% CI 1.58 to 4.18
Moderate effect size hydrocolloid dressings

Adverse effects

No data from the following reference on this outcome.

Hydrocolloid dressings versus non-hydrocolloid dressings other than gauze soaked in saline, hypochlorite, or povidone iodine:

We found one systematic review (search date 2008), which compared hydrocolloid dressings versus other dressings. The review did not pool data. Overall, the review concluded that no one dressing was consistently superior to the alternatives.

Healing rates

Hydrocolloid dressings compared with non-hydrocolloid dressings other than gauze soaked in saline, hypochlorite, or povidone iodine We don't know whether hydrocolloid dressings are more effective at healing pressure ulcers (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Healing rates

Systematic review
Number of people unclear
8 RCTs in this analysis
Wound healing
with hydrocolloid dressings
with other types of dressing
Absolute results not reported

Reported as not significant
P value not reported
Not significant

Adverse effects

No data from the following reference on this outcome.

Hydrocolloid dressings versus topical phenytoin:

See option on topical phenytoin.

Dressings other than hydrocolloid versus each other:

We found one systematic review (search date 2008), which compared dressings other than hydrocolloid versus each other. The review categorised dressings by their primary purpose (e.g., debriding, hydrating, absorbent, etc.) and only included studies that calculated wound size, used evaluation tools that incorporated these measurements, or used complete wound healing as end points. Overall, the review found no clear evidence that any one dressing was consistently superior to any other dressing (no further data reported; see further information on studies for details of RCTs).

Adverse effects

No data from the following reference on this outcome.

Further information on studies

The review included RCTs comparing different debriding dressings (3 RCTs), debriding versus absorbent dressings (1 RCT), absorbent dressings versus each other (2 RCTs), absorbent versus other specific dressings (3 RCTs), hydrating versus absorbent dressings (2 RCTs), hydrating versus antimicrobial dressings (1 RCT), hydrating versus other specific dressings (3 RCTs), antimicrobial versus other specific dressings (4 RCTs), and other specific dressings versus other specific dressings (13 RCTs). Many of the RCTs were of poor methodological quality (CLEAR NPT criteria [maximum 6]: 24 RCTs scored 2 or less), were small (20 RCTs included 40 people or less), and many had large differences between the number randomised and those who completed the study.

Hydrocolloid dressings versus gauze soaked in saline, hypochlorite, or povidone iodine: Given the large absolute risks of events in this review, a relative risk would be a preferable outcome measure for results. If the meta-analysis is re-worked using relative risk instead of odds ratio, the result is no longer significant (Cullum N, 2004; personal communication).

Comment

None.

Substantive changes

Dressings (hydrocolloid and non-hydrocolloid) versus each other to treat pressure ulcers Option restructured. Previous options of 'Hydrocolloid dressings to treat pressure ulcers' and 'Dressings other than hydrocolloid to treat pressure ulcers' reported in one option of 'Dressings (hydrocolloid and non-hydrocolloid) versus each other to treat pressure ulcers'. New evidence added. 'Dressings (one type versus any other type)' categorised as Unknown effectiveness as we found no evidence that any one type of dressing is consistently more effective than all other types of dressings.

BMJ Clin Evid. 2011 May 5;2011:1901.

Electrotherapy to treat pressure ulcers

Summary

We don't know whether electrotherapy improves healing in people with pressure ulcers.

Benefits and harms

Electrotherapy versus sham electrotherapy or standard treatment:

We found two systematic reviews (search dates 2000 and 2008) and one subsequent RCT. The second review did not pool data.

Healing rates

Compared with sham electrotherapy or standard treatment We don't know whether electrotherapy is more effective than sham electrotherapy or standard care at healing pressure ulcers as we found insufficient evidence (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Healing rates

Systematic review
Number of people unclear
2 RCTs in this analysis
Healing rates 3 to 5 weeks
with electrotherapy
with sham treatment
Absolute results not reported

RR 7.92
95% CI 2.40 to 26.30
Large effect size electrotherapy

Systematic review
49 people
In review
Percentage area of pressure ulcer healed 4 weeks
50% with electrotherapy
23% with sham treatment

P = 0.04
Effect size not calculated electrotherapy

Systematic review
7 people
Data from 1 RCT
Reduction in wound surface area
22% with interrupted direct current
3% with placebo-interrupted direct current

P value not reported

RCT
63 people
In review
Proportion of people completely healed 8 weeks
5/35 (14%) with electrotherapy
3/28 (11%) with sham treatment

P = 0.39
Not significant

Systematic review
63 people
In review
Proportion of people completely healed 12 weeks
9/35 (26%) with electrotherapy
10/28 (36%) with sham treatment

P = 0.28
Not significant

RCT
63 people
In review
Mean time to complete healing
63 days with electrotherapy
90 days with sham treatment

P = 0.16
Not significant

RCT
34 people with spinal cord injury, grade II to IV ulcers, average age 50 years Mean decrease in percentage wound surface area 3 months
70% with high-voltage pulsed current plus standard care
36% with standard care

P = 0.048
Borderline significance
Effect size not calculated high-voltage pulsed current plus standard care

Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects

RCT
63 people
In review
Adverse effects
with electrotherapy
with sham treatment
Absolute results not reported

2 people in the electrotherapy group had hypergranulation of the ulcer, and 2 had local irritation (2/35 [6%] for either outcome), possibly as a result of concomitant use of topical sulfadiazine cream

RCT
34 people Adverse effects
with electrotherapy plus standard care
with standard care alone
Absolute results not reported

The RCT noted that adverse effects were minor and rare, the most common with electrotherapy plus standard care was red, raised, itchy skin under the large dispersive electrode, which was attributed to contact dermatitis

No data from the following reference on this outcome.

Further information on studies

None.

Comment

None.

Substantive changes

Electrotherapy to treat pressure ulcers New evidence added. Categorisation unchanged (Unknown effectiveness), as there remains insufficient evidence to judge the effects of this intervention.

BMJ Clin Evid. 2011 May 5;2011:1901.

Low-air-loss beds to treat pressure ulcers

Summary

We don't know whether low-air-loss beds improve healing in people with pressure ulcers.

Benefits and harms

Low-air-loss beds versus standard beds or standard care:

We found two systematic reviews (search dates 2000 and 2008).

Healing rates

Compared with standard beds or standard care We don't know whether low-air-loss beds are more effective at increasing pressure ulcer healing (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Healing rates

Systematic review
133 people
2 RCTs in this analysis
Healing rate
with low-air-loss beds
with convoluted foam
Absolute results not reported

RR 1.25
95% CI 0.84 to 1.86
The meta-analysis may have been underpowered to detect a clinically important difference between groups
Not significant

Systematic review
20 people, age range 36 to 100 years, acute and long-term care, grade III or IV ulcers Mean rate of wound closure per week
5% with low-air-loss mattress
9% with air and foam mattress

P value not reported

Systematic review
207 people, mean age 69 years, long-term care, grade III or IV ulcers
Data from 1 RCT
Time to complete healing
4.38 months with low-air-loss mattress
4.55 months with specialised foam mattress overlay
3.33 months with alternating pressure

P value not reported

Systematic review
207 people, mean age 69 years, long-term care, grade III or IV ulcers
Data from 1 RCT
Mean improvement in Pressure Sore Status Score
18.4 with low-air-loss mattress
34.3 with alternating-pressure mattress

P <0.001
Effect size not calculated alternating-pressure mattress

Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects

RCT
Number of participants unclear
In review
Hypothermia
with low-air-loss hydrotherapy beds
with standard care
Absolute results not reported

Hypothermia was found in a small number of people who used low-air-loss hydrotherapy beds (no further data reported by review)

No data from the following reference on this outcome.

Further information on studies

None.

Comment

None.

Substantive changes

Low-air-loss beds to treat pressure ulcers New evidence added. Categorisation unchanged (Unknown effectiveness), as there remains insufficient evidence on effects of this intervention.

BMJ Clin Evid. 2011 May 5;2011:1901.

Low-level laser treatment to treat pressure ulcers

Summary

We don't know whether low-level laser therapy improves healing in people with pressure ulcers.

Benefits and harms

Low-level laser treatment versus standard care or sham treatment:

We found one systematic review (search date 2008), which included RCTs that calculated wound size with wound volume or surface area, used evaluation tools that included these measurements, or used complete wound healing as an end point. The review included two RCTs.

Healing rates

Compared with standard care/sham treatment We don't know whether laser treatment is more effective than standard care at increasing pressure ulcer healing (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Healing rates

Systematic review
86 people (79 people completed study), age range 49 to 100 years, long-term care, grade III ulcers
Data from 1 RCT
Reduction in wound surface area
with low-level laser
with standard care
Absolute results not reported

P = 0.23
Not significant

Systematic review
35 people (25 people completed study), age range 8 to 65 years, rehabilitation, grade II to IV ulcers
Data from 1 RCT
Time to complete wound healing
2.45 weeks with laser plus moist saline gauze
1.78 weeks with saline gauze alone

P = 0.33
Not significant

Adverse effects

No data from the following reference on this outcome.

Low-level laser treatment versus ultrasound plus ultraviolet light:

See option on therapeutic ultrasound.

Further information on studies

None.

Comment

None.

Substantive changes

Low-level laser treatment to treat pressure ulcers New evidence added. Categorisation unchanged (Unknown effectiveness), as there remains insufficient evidence to judge the effects of this intervention.

BMJ Clin Evid. 2011 May 5;2011:1901.

Low-tech constant-low-pressure supports to treat pressure ulcers

Summary

We don't know whether low-tech constant-low-pressure supports improve healing in people with pressure ulcers.

Benefits and harms

Low-tech constant-low-pressure supports versus each other:

We found two systematic reviews (search dates 2000 and 2008), which identified the same RCT.

Healing rates

Compared with each other We don't know whether a layered-foam replacement mattress is more effective than a water mattress at increasing healing of pressure ulcers at 4 weeks in elderly people in a nursing home (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Healing rates

Systematic review
120 elderly people with pressure ulcers in a nursing home, 101 completed study, grade III or IV
Data from 1 RCT
Complete ulcer healing 4 weeks
45% with layered-foam replacement mattress
48% with water mattress
Absolute numbers not reported

Reported as not significant
P value not reported
Not significant

Adverse effects

No data from the following reference on this outcome.

Further information on studies

None.

Comment

None.

Substantive changes

Low-tech constant-low-pressure supports to treat pressure ulcers New evidence added. Categorisation unchanged (Unknown effectiveness), as there remains insufficient evidence to judge the effects of this intervention.

BMJ Clin Evid. 2011 May 5;2011:1901.

Nutritional supplements to treat pressure ulcers

Summary

We don't know whether nutritional interventions improve healing in people with pressure ulcers.

Benefits and harms

Nutritional supplements versus control:

We found two systematic reviews (search dates 2002 and 2008) and one subsequent RCT.

Healing rates

Compared with control (low dose or no supplements) We don't know whether nutritional supplements are more effective than control at increasing healing of pressure ulcers (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Healing rates

Systematic review
88 people with pressure ulcers in nursing homes or hospital, some of whom were receiving ultrasound treatment for their pressure ulcers
Data from 1 RCT
Ulcer healing 84 days
17/43 (39%) with ascorbic acid 1000 mg daily
22/45 (49%) with ascorbic acid 20 mg daily

RR 0.81
95% CI 0.50 to 1.30
Not significant

Systematic review
20 people with pressure ulcers having surgery
Data from 1 RCT
Ulcer healing 4 weeks
with ascorbic acid 1000 mg daily
with placebo
Absolute results not reported

RR 2.00
95% CI 0.68 to 5.85
Not significant

Systematic review
12 institutionalised people being fed through a tube
Data from 1 RCT
Ulcer healing 8 weeks
with very high-protein diet
with high-protein diet
Absolute results not reported

RR 0.11
95% CI 0.01 to 1.70
Not significant

Systematic review
20 people with pressure ulcers having surgery
Data from 1 RCT
Mean reduction in would surface 1 month
84% with ascorbic acid 1000 mg daily
43% with placebo

P <0.005
Effect size not calculated ascorbic acid

RCT
3-armed trial
16 people with stage 2 or 3 pressure ulcers
In review
Mean score Pressure Ulcer Scale for Healing (PUSH) 3 weeks
7 with diet A
6 with diet B
2.6 with diet C

Diet C v Diet A and B: P <0.05
This study randomised only 16 people between the 3 groups and did not report the proportion of participants with complete healing
Effect size not calculated standard hospital diet plus 500 kcal, protein 21 g, vitamin C 500 mg, zinc 30 mg, and arginine 9 g

RCT
89 people resident in long-term care facilities with stage II, III, or IV pressure ulcers
In review
PUSH 8 weeks
3.55 with concentrated, fortified, collagen protein hydrolysate supplement
3.22 with placebo

P <0.05
However, these results should be interpreted with caution, as groups were imbalanced at baseline (mean PUSH scores at baseline: 9.11 in people taking supplements v 6.07 in people taking placebo) and results were not based on an intention-to-treat analysis
Effect size not calculated nutritional supplements

Systematic review
95 people (80 completed study), age range 22 to 102 years, acute care, grade I to IV ulcers, trial duration 1 week
Data from 1 RCT
Adjusted mean change in ulcer size on wound surface area
2.70 with standard care plus standard diet
2.76 with consistent wound care
2.60 with controlled nutritional support
2.34 with consistent wound care plus controlled nutritional support

Reported as not significant for any comparison
P value not reported
Not significant

RCT
30 people, aged 65 years or over, recent onset (<1-month history) grade II to IV ulcers, orally or tube fed PUSH change from baseline 12 weeks
6.1 with disease-specific nutrition treatment
3.3 with standard diet

P <0.05
Analysis was not by intention to treat (2 people were excluded), only people with recent pressure ulcers were included in the trial, and people who were tube fed or fed orally were not analysed separately
Effect size not calculated disease-specific nutrition treatment

Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects

RCT
Number of people unclear
In review
Adverse effects
with nutritional supplements
with placebo

11/44 (25%) people discontinued treatment because of adverse effects (2 with hip fracture because of fall; 3 because of changes in renal laboratory values; 4 with nausea or distension; 2 died), but the RCT did not report data for each group separately, except to say that 1 person in each group died from causes unrelated to treatment

No data from the following reference on this outcome.

Further information on studies

Many of the RCTs were small and may have lacked power to detect clinically important differences between treatments. The fourth included RCT (14 people) identified by the first review was a crossover RCT that did not report results before the crossover period, and had a high withdrawal rate.

This review included three RCTs included in the first review and 4 further RCTs. Many of the RCTs were small and may have lacked power to detect clinically important differences between treatments. The third included RCT (36 people, age range 72–91 years, 2 weeks' trial duration) identified by the second review compared standard hospital diet, standard diet plus high protein, and standard diet plus high protein plus arginine, zinc, and antioxidants. The RCT was of poor methodological quality and data on Pressure Score Status Tool scores were not available.

Comment

None.

Substantive changes

Nutritional supplements to treat pressure ulcers New evidence added. Categorisation unchanged (Unknown effectiveness), as there remains insufficient evidence to judge the effects of this intervention.

BMJ Clin Evid. 2011 May 5;2011:1901.

Seat cushions to treat pressure ulcers

Summary

We don't know whether seat cushions improve healing in people with pressure ulcers.

Benefits and harms

Seat cushions versus each other or standard care:

We found two systematic reviews (search dates 2000 and 2008).

Healing rates

Compared with each other or standard care We don't know whether seat cushions are more effective than standard care at reducing time to complete healing, or whether different seat cushions differ in effectiveness at increasing pressure ulcer healing (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Healing rates

Systematic review
28 people
Data from 1 RCT
Complete healing
with cushion with dry flotation
with alternating-pressure cushion
Absolute results not reported

Reported as not significant
P value not reported
Not significant

RCT
3-armed trial
207 people with grade 3 and 4 pressure ulcers
In review
Mean time to complete healing 6 months
3.33 months with bespoke, moulded seat containing alternating-pressure air sacs
4.55 months with solid-foam bed overlay 8.9 cm thick
4.38 with low-air-loss mattress

P value not reported
See further information about studies for details on trial methods

RCT
3-armed trial
207 people with grade 3 and 4 pressure ulcers
In review
Mean improvement in Pressure Sore Status Score
34.3 with bespoke, moulded seat containing alternating-pressure air sacs
18.4 with low-air-loss mattress

P <0.001
See further information about studies for details on trial methods
Effect size not calculated alternating-pressure mattress

Adverse effects

No data from the following reference on this outcome.

Further information on studies

The RCT had several flaws, including a lack of intention-to-treat analysis (participants who worsened were excluded from analysis), and a primary outcome that was determined by the results of the trial.

Comment

None.

Substantive changes

Seat cushions to treat pressure ulcers New evidence added. Categorisation unchanged (Unknown effectiveness), as there remains insufficient evidence to judge the effects of this intervention.

BMJ Clin Evid. 2011 May 5;2011:1901.

Surgery to treat pressure ulcers

Summary

We found no direct information from RCTs about surgery in the treatment of pressure ulcers.

Benefits and harms

Surgery versus no surgery/other interventions:

We found no systematic review or RCTs of surgical treatments for pressure ulcers.

Further information on studies

None.

Comment

None.

Substantive changes

No new evidence

BMJ Clin Evid. 2011 May 5;2011:1901.

Therapeutic ultrasound to treat pressure ulcers

Summary

We don't know whether ultrasound improves healing of pressure ulcers.

Benefits and harms

Ultrasound versus sham ultrasound:

We found one systematic review (search date 2008, 3 RCTs). The review reported that all three RCTs were small (40 people; 18 people; 88 people), allocation concealment was not stated in two RCTs, and an intention-to-treat analysis was not performed in two RCTs. All three RCTs used blinded outcomes assessments.

Healing rates

Compared with sham ultrasound We don't know whether therapeutic ultrasound is more effective than sham ultrasound at increasing the number of sores healed (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Healing rates

Systematic review
128 people
2 RCTs in this analysis
Number of sores healed
with therapeutic ultrasound
with sham ultrasound
Absolute results not reported

RR 0.97
95% CI 0.65 to 1.45
Not significant

Adverse effects

No data from the following reference on this outcome.

Ultrasound plus ultraviolet light versus standard care or versus laser treatment:

We found one systematic review (search date 2008, 3 RCTs). The review reported that all three RCTs were small (40 people; 18 people; 88 people), allocation concealment was not stated in two RCTs, and an intention-to-treat analysis was not performed in two RCTs. All three RCTs used blinded outcomes assessments.

Healing rates

Ultrasound plus ultraviolet light compared with standard care or laser treatment We don't know whether ultrasound plus ultraviolet light is more effective than standard care or laser treatment at increasing the number of sores healed at 12 weeks. (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Healing rates

Systematic review
20 people
Data from 1 RCT
Number of sores healed 12 weeks
6/6 (100%) with ultrasound plus UV
5/6 (83%) with standard care

RR 1.18
95% CI 0.76 to 1.83
The RCT was underpowered to detect clinically important differences between groups
Not significant

Systematic review
20 people
Data from 1 RCT
Number of sores healed 12 weeks
6/6 (100%) with ultrasound plus UV
4/6 (67%) with laser treatment

RR 1.44
95% CI 0.80 to 2.60
The RCT was underpowered to detect clinically important differences between groups
Not significant

Adverse effects

No data from the following reference on this outcome.

Further information on studies

None.

Comment

None.

Substantive changes

Therapeutic ultrasound to treat pressure ulcers Search updated for already included systematic review. New evidence added. Categorisation unchanged (Unknown effectiveness), as there remains insufficient evidence to judge the effects of this intervention.

BMJ Clin Evid. 2011 May 5;2011:1901.

Topical negative pressure to treat pressure ulcers

Summary

We don't know whether topical negative pressure improves healing of pressure ulcers.

Benefits and harms

Topical negative pressure versus control:

We found three systematic reviews (search dates 2007 and 2008), which examined the effects of topical negative pressure. One review identified 5 RCTs and one review of topical negative pressure for treating chronic wounds identified 7 RCTs. However, not all the RCTs were solely in people with pressure ulcers, and the RCTs did not separately report results for people with pressure ulcers only, so we have not reported these RCTs further. All three reviews identified the same two RCTs, which were solely in people with pressure ulcers. Both RCTs were of poor methodological quality (CLEAR NPT criteria [maximum 6]; first RCT, score 0; second RCT, score 2).

Healing rates

Compared with control We don't know whether topical negative pressure is more effective than gauze soaked in Ringer's solution or a regimen of three gel products at increasing healing of pressure ulcers (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Healing rates

Systematic review
22 people
Data from 1 RCT
Mean time to reach 50% reduction in initial wound volume
with topical negative pressure
with gauze soaked in Ringer's solution
Absolute results not reported

Mean difference –1.00 days
95% CI –0.82 days to +6.21 days
Not significant

Systematic review
35 people
Data from 1 RCT
Wound surface reduction
51.8% with topical negative pressure
42.1% with regimen of three gel products
Absolute numbers not reported

P = 0.46
Not significant

Adverse effects

No data from the following reference on this outcome.

Further information on studies

None.

Comment

None.

Substantive changes

Topical negative pressure to treat pressure ulcers New evidence added. Categorisation unchanged (Unknown effectiveness), as there remains insufficient evidence to judge the effects of this intervention.

BMJ Clin Evid. 2011 May 5;2011:1901.

Topical phenytoin to treat pressure ulcers

Summary

We don't know whether phenytoin improves healing of pressure ulcers.

Benefits and harms

Topical phenytoin versus control/standard treatment:

We found one systematic review (search date 2008), which found three RCTs.

Healing rates

Compared with hydrocolloid/standard dressings or antibiotic ointment We don't know whether topical phenytoin ointment is more effective at increasing pressure ulcer healing (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Healing rates

RCT
48 people
In review
Mean time to healing
35.3 days with topical phenytoin suspension (100 mg capsule in 5 mL saline)
51.8 days with hydrocolloid dressings or antibiotic ointment

P <0.005
Effect size not calculated topical phenytoin suspension

RCT
3-armed trial
83 people
In review
Complete ulcer healing
11/28 (39%) with topical phenytoin
20/28 (71%) with hydrocolloid dressings

ARR 32%
95% CI 7.4% to 56.7%
Effect size not calculated topical phenytoin

RCT
3-armed trial
83 people
In review
Complete ulcer healing
11/28 (39%) with topical phenytoin
8/27 (30%) with standard dressings

P value not reported

Systematic review
28 people, mean age 31 to 34 years, rehabilitation, trial duration 2 weeks, grade II ulcers
Data from 1 RCT
Mean reduction in Pressure Ulcer Scale for Healing (PUSH) scores 2 weeks
19.53 with phenytoin solution
11.39 with normal saline

P = 0.26
Not significant

Adverse effects

No data from the following reference on this outcome.

Further information on studies

None.

Comment

Clinical guide:

Topical phenytoin is an experimental treatment rarely used in current clinical practice.

Substantive changes

Topical phenytoin to treat pressure ulcers New evidence added. Categorisation unchanged (Unknown effectiveness), as there remains insufficient evidence to judge the effects of this intervention.


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