Abstract
Introduction
Unrelieved pressure or friction of the skin, particularly over bony prominences, can lead to pressure ulcers in up to a third of people in hospitals or community care, and a 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 February 2007 (BMJ 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 60 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 a third of people in hospitals or community care, and a 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.
Low-air-loss beds may reduce the risk of pressure ulcers compared with standard intensive-care beds, but we don't know whether pressure-relieving overlays on operating tables are also beneficial compared with other pressure-relieving surfaces.
Medical sheepskin overlays may reduce the risk of pressure ulcers compared with standard care.
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.
We don't know if other physical interventions, such as alternating pressure surfaces, seat cushions, electric profiling beds, low-tech constant low pressure supports, repositioning, or topical lotions and dressings are effective for preventing pressure ulcers. We also don't know whether pressure ulcers can be prevented by use of nutritional interventions.
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.
Hydrocolloid dressings may also improve healing rates compared with standard dressings.
We don't know whether healing is improved in people with pressure ulcers by use of other treatments such as alternating pressure surfaces, debriding agents, low-tech constant low pressure supports, low-air-loss beds, seat cushions, dressings other than hydrocolloid, topical phenytoin, surgery, electrotherapy, ultrasound, low level laser therapy, topical negative pressure, 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 4.7-32.1% for hospital populations, 4.4-33.0% for community-care populations, and 4.6-20.7% 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 little data on prognosis of untreated pressure ulcers. The presence of pressure ulcers has been associated with a two- to fourfold 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
Incidence and severity of pressure ulcers; rate of change of area and volume; time to heal; and 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
BMJ Clinical Evidence search and appraisal February 2007. The following databases were used to identify studies for this systematic review: Medline 1966 to February 2007, Embase 1980 to February 2007, and The Cochrane Library (all databases) 2007, Issue 1. Additional searches were carried out using these websites: NHS Centre for Reviews and Dissemination (CRD) — all databases, Turning Research into Practice (TRIP), and NICE. Abstracts of the studies retrieved from the initial search were assessed by an information specialist. Selected studies were then sent to the author for additional assessment, using pre-determined criteria to identify relevant studies. Study-design criteria for inclusion in this review were: published systematic reviews 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. In addition, we use a regular surveillance protocol to capture harms alerts from organisations such as the FDA and the UK Medicines and Healthcare products Regulatory Agency (MHRA), which are added to the reviews as required. 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. We have performed a GRADE evaluation of the quality of evidence for interventions included in this review (see table ).
Table.
GRADE evaluation of interventions for pressure ulcers
| Important outcomes | Incidence of pressure ulcers, symptom severity, time to heal | ||||||||
| Number of 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) | Incidence of pressure ulcers | Foam alternatives v standard hospital mattresses | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for incomplete reporting of results and poor-quality RCTs |
| 1 (40) | Incidence of pressure ulcers | Foam alternatives compared with each other | 4 | –3 | 0 | 0 | +1 | Low | Quality points deducted for sparse data, incomplete reporting of results, and poor-quality RCTs. Effect-size point added for RR less than 0.5 |
| 5 (1402) | Incidence of pressure ulcers | Pressure-relieving overlays on operating tables v standard table alone | 4 | –2 | –1 | 0 | 0 | Very low | Quality points deducted for incomplete reporting of results and poor-quality RCTs. Consistency point deducted for conflicting results |
| 2 (160) | Incidence of pressure ulcers | Low-air-loss beds v standard intensive care beds/alternating pressure mattresses | 4 | –2 | –1 | 0 | 0 | Very low | Quality points deducted for sparse data and incomplete reporting of results. Consistency point deducted for conflicting results |
| 2 (748) | Incidence of pressure ulcers | Medical sheepskin overlays v standard care | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for no intention-to-treat analysis |
| 2 (435) | Incidence of pressure ulcers | Alternating pressure surfaces v standard foam mattress | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for incomplete reporting of results, no intention-to-treat analysis, poor follow-up, and poor-quality RCTs |
| 9 (1466) | Incidence of pressure ulcers | Alternating pressure surfaces v constant low pressure supports | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for incomplete reporting of results, uncertainty about follow-up, and poor-quality RCTs |
| 2 (2153) | Incidence of pressure ulcers | Alternating pressure surfaces v each other | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for incomplete reporting of results and poor-quality RCTs |
| 4 (473) | Incidence of pressure ulcers | Seat cushions v each other | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 1 (70) | Incidence of pressure ulcers | Electric profiling beds v standard hospital beds | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| 7 (1451) | Incidence of pressure ulcers | Low-tech constant low pressure supports v other pressure-relieving devices | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for incomplete reporting of results and poor-quality RCTs. Directness point deducted for uncertainty about benefit |
| 5 (1475) | Incidence of pressure ulcers | Nutritional supplements v control/standard care | 4 | –3 | 0 | –1 | 0 | Very low | Quality points deducted for incomplete reporting of results and for methodological flaws. Directness point deducted for baseline differences between groups |
| 4 (1055) | Incidence of pressure ulcers | Repositioning (including regular turning) v standard care | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for incomplete reporting of results, poor-quality RCTs, and methodological flaws |
| 1 (807) | Incidence of pressure ulcers | Repositioning at 30 ° tilt v a 90 ° lateral and supine position | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for uncertainty about benefit |
| 3 (618) | Incidence of pressure ulcers | Topical lotions v topical placebo/ other lotions | 4 | –2 | –1 | 0 | 0 | Very low | Quality points deducted for incomplete reporting of results and no intention-to-treat analysis. Consistency point deducted for conflicting results |
| 1 (52) | Incidence of pressure ulcers | Air-filled vinyl boots v hospital pillows | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 1 (111) | Incidence of pressure ulcers | Hydrocellular heel supports v orthopaedic wool padding | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and no intention-to-treat analysis |
| 1 (98) | Incidence of pressure ulcers | Low-air-loss hydrotherapy beds v support surfaces | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| What are the effects of treatments in people with pressure ulcers? | |||||||||
| 3 (202) | Healing rates | Air-fluidised support v standard care | 4 | –2 | –1 | –1 | 0 | Very low | Quality points deducted for incomplete reporting of results and no intention-to-treat analysis. Consistency point deducted for conflicting results. Directness point deducted for uncertainty about generalisability of benefits |
| 4 (372) | Healing rates | Alternating pressure surfaces v each other/standard care | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 5 (246) | Healing rates | Debriding agents v each other | 4 | –1 | 0 | –2 | 0 | Very low | Quality point deducted for incomplete reporting of results. Directness points deducted for inclusion of range of wounds and for uncertainty about relative effectiveness of agents |
| 8 (at least 472 wounds) | Healing rates | Hydrocolloid dressings v gauze soaked in saline, hypochloride, or povidone iodine | 4 | –2 | –1 | –1 | 0 | Very low | Quality points deducted for incomplete reporting of results and inclusion of poor-quality RCTs. Consistency point deducted for conflicting results. Directness point deducted for baseline differences in ulcer sizes between groups |
| 1 (110) | Healing rates | Hydrocolloid dressings v other dressings | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 3 (135) | Healing rates | Dressings other than hydrocolloids v each other | 4 | –2 | –1 | 0 | 0 | Very low | Quality points deducted for sparse data and incomplete reporting of results. Consistency point deducted for different results for different dressings |
| 4 (at least 112 people) | Healing rates | Electrotherapy v sham electrotherapy | 4 | –2 | –1 | 0 | 0 | Very low | Quality points deducted for incomplete reporting of results and inclusion of poor-methodology RCTs. Consistency point deducted for conflicting results |
| 2 (133) | Healing rates | Low-air-loss beds v convoluted foam | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| 4 (200) | Healing rates | Laser treatment v standard care/sham treatment | 4 | –3 | –1 | 0 | 0 | Very low | Quality points deducted for poor-quality RCTs, incomplete reporting of results, no intention-to-treat analysis, and poor and short follow-up. Consistency point deducted for conflicting results |
| 1 (120) | Healing rates | Low-tech constant low pressure supports v each other | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| 5 (225) | Healing rates | Nutritional supplements v control (low dose or no supplements) | 4 | –2 | –1 | 0 | 0 | Very low | Quality points deducted for poor methodologies (randomisation flaws, no intention-to-treat analysis, poor follow-up). Consistency point deducted for conflicting results |
| 2 (235) | Healing rates | Seat cushions compared with each other | 4 | –3 | –1 | 0 | 0 | Very low | Quality points deducted for incomplete reporting of results and methodological flaws. Consistency point deducted for conflicting results |
| 2 (128) | Healing rates | Ultrasound v sham ultrasound | 4 | –3 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| 1 (12) | Healing rates | Ultrasound plus ultraviolet v standard care v laser treatment | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 6 (128) | Healing rates | Topical negative pressure v control | 4 | –3 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data, incomplete reporting of results, and weak methodologies. Directness points deducted for baseline differences in wound severity |
| 2 (131) | Healing rates | Topical phenytoin v hydrocolloid or standard dressings/antibiotic ointment | 4 | –1 | –1 | –1 | 0 | Very low | Quality point deducted for sparse data. Consistency point deducted for conflicting results. Directness points deducted for baseline differences in ulcer sizes |
Type of evidence: 4 = RCT; 2 = Observational; 1 = Non-analytical/expert opinion. Consistency: similarity of results across studies Directness: generalisability of population or outcomes Effect size: based on relative risk or odds 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.
- Braden Scale
Assesses a person's risk of developing a pressure ulcer. It has six subscales: mobility, activity, nutrition, moisture, sensory perception, and friction and shear. The score scale ranges from 6 to 23, with a lower score indicating a greater risk of developing a pressure ulcer.
- Dextranomer paste
Anhydrous, porous beads 0.1–0.3 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-level laser therapy
Also known as low-intensity or low-power therapy. It is thought to work by inducing a photochemical response to laser light, which results in biochemical alterations in cells and physiological changes.
- 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.
Contributor Information
Professor Nicky A Cullum, Department of Health Sciences, University of York, York, UK.
Dr Emily Petherick, Department of Health Sciences, University of York, York, UK.
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