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. 2017 Apr 6;2017(4):CD011543. doi: 10.1002/14651858.CD011543.pub2

Pressure garment therapy for preventing hypertrophic and keloid scarring after a major burn injury

Jing Lu 1, Ting Xu 1,✉, Yong Liu 2, Ming Yang 3, Xuehua Jiang 4
PMCID: PMC6478061

Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

To assess the effects of pressure garment therapy (PGT) for preventing abnormal scarring after burn injury.

Background

Description of the condition

In 2004, it was estimated that nearly 11 million people worldwide suffered burns severe enough to warrant medical attention (Peck 2011). Despite advances in burn care, abnormal scarring is the most common and frustrating complication (Herndon 2012). According to the study by Esselman 2006, burn scarring occurred in up to 70% of cases, depending on the age, gender and severity of burns. It is reported that scar formation is an inevitable endpoint of full thickness skin injury (Urioste 1999). Scarring is a healing process of the skin in response to the burn injury, and the imbalance of inflammatory and maturation phases in wound healing contributes to scar formation. A prolonged inflammatory phase resulting in exaggerated cytokine activation could increase risk of scarring, and in the maturation phase, the co‐action of macrophages, fibroblasts and vessels re‐establish dermal integrity, and anti‐fibrotic factors inhibit fibroblast synthesis (Urioste 1999). Abnormal scarring, is correlative with the disproportionate deposition of collagen during the wound reparative process, often taking the forms of hypertrophic or keloid scars. People with burn injuries can take a long time to recuperate; development of scarring in this process not only presents the patient with cosmetic issues but also can cause problems with loss of function (Ripper 2009).

Hypertrophic and keloid scars are difficult to manage and the mechanisms by which they develop are not fully understood; they can both be characterised by the deposition of collagen fibres or bundles in the dermis. Clinically, hypertrophic scars result from the wound healing process, do not grow outside of the confines of the original wound and are normally red, thick and may be painful or itchy. The scar starts developing within a few weeks and occasionally improves without intervention (Urioste 1999). Keloids are defined as scars growing beyond the original margins of wounds (Tuan 1998), they appear as firmer, reddish‐purple nodules consisting of a mass of collagen, encircled by numerous small vessels (Urioste 1999). Keloid development cannot be predicted, and their development is more prominent in certain populations; people with dark skin (African) and Asians are more often affected. Different repair mechanisms after a burn injury lead to a wide range of different scars, which are classified clinically through the site by appearance, colour and scar assessment scale. A large number of scar assessment scales are available, most of them assess the vascularity, pliability, height and thickness of the scar. The Patient and Observer Scar Assessment Scale (POSAS) and the Vancouver Scar Scale (VSS) are commonly used. The POSAS, with high quality reliability but indeterminate validity, is considered to be preferable, based on the available evidence. The VSS has the most thorough review on clinimetrics, but the available data were indeterminate (Tyack 2011).

Treatments for hypertrophic and keloid scars include: pressure therapy, radiation and laser treatment with varying degrees of success. The mechanisms of action of these treatments are:

  1. manipulation of the mechanical properties of wound repair;

  2. correction of the abnormal balance of matrix degradation and collagen biosynthesis;

  3. alteration of the immune/inflammatory response (Tsao 2002).

Generally, multiple treatments undertaken simultaneously and sequentially have shown to have better outcomes (Juckett 2009).

Description of the intervention

Pressure garment therapy (PGT) is considered to be an effective strategy for the management of abnormal scarring (Carr‐Collins 1992; Ward 1992; Endorf 2011). PGT has been the mainstay intervention for preventing hypertropic scarring since the early 1970s; its use for keloid scarring was first reported in 1835. PGT for people with burn wounds has been used in several studies, such as, the histological/dermatological illustration of its mechanism (Judge 1984; Reno 2001), clinical practice (Staley 1997; Stewart 2000) and a case‐study (Linares 1993). The clinical effectiveness of pressure therapy has been advocated but never scientifically proven, with uncertainty existing as a result. Disadvantages of the therapy (which are thought to restrict clinical use) include high costs and potential patient morbidity, along with overheating, itching, wound breakdown, emotional distress and abnormal bone growth due to use over a long time period (Johnson 1994; Fricke 1999).

Pressure garments are made from fabrics with an elastic component, which exert pressure on any part of the body. One study compared the fabrics and claimed that soft, flexible and extensible fabrics with good elastic recovery, with a thickness of 3.81 mm were recommended (Nilüfer 2007). Ready‐to‐wear pressure garments and custom‐made pressure garments are available. The former are not normally used due to poor fitting and the need for adjustment; the latter are more suitable and are therefore widely used in pressure therapy (NG 1995).

The pressure garment is designed to exert a pressure of approximately 25 mmHg on the underlying tissue in order to exceed the inherent capillary pressure (Nilüfer 2007). The range of pressure varies and the 'ideal' pressure has not been scientifically established. An investigation using a novel technique to determine the exact pressure on the applied body part, found no difference between the pressure calculated experimentally on a mannequin leg at 24 mmHg compared to the optimum pressure of 20 mmHg (Nilüfer 2007).

In practice, it is important to begin treatment with a pressure garment as soon as possible due to the fact that the scar responds well to pressure during the first stage of its development, immediately after the wound has been closed. It normally takes at least six months from wound closure to scar maturation (Linares 1993), however, some studies have recommended 12 months and up to three years (Staley 1997; Hubbard 2000). A person has to wear the garment at least 23 hours per day to provide adequate, consistent and sustained pressure during pressure therapy (Williams 1998). The long period of time required for wearing the pressure garment plus the associated restriction of movement, discomfort from heat and perspiration, and poor appearance of the garment often leads to poor compliance and discontinuation of treatment (Brown 2001). A study showed that only 41% of people completed their course of pressure therapy due to these drawbacks and lack of perceived benefit for scar improvement (Sawada 1994; Hubbard 2000; Stewart 2000).

How the intervention might work

The exact mechanisms of pressure garment therapy are not fully understood, but there are several standpoints to support its use. Firstly, the application of constant pressure during the scar maturation may limit the supply of blood, oxygen and nutrients to the scar tissue. This in turn may control collagen synthesis (Reid 1987; Staley 1997; Engrav 2010). Secondly, the continuous pressure exertion limits the collagen synthesis in the scar and speeds up the natural maturation process (Reid 1987), as a result the structure of the scar takes on a more normal appearance (Eberlein 2004; Spilker 2002). Finally, the pressure may encourage the realignment of collagen bundles already present, which in turn may be associated with decreasing the hydration of the scar, reducing neo vascularisation and extracellular matrix production (Puzey 2002).

Why it is important to do this review

PGT is commonly used to prevent abnormal scarring in people with burn wounds, however the evidence base is not clear. Unfortunately, the high costs, length of time required to wear the garments and the associated discomfort of the garment have restricted its application in clinical practice. A systematic review was conducted to assess its efficacy in 2009 (Anzarut 2009), and found that any beneficial effects remained unproven. This review included only a small number of studies, did not report adverse events, and the search date was up to 2006. Therefore, an up‐to‐date assessment of all current evidence is warranted.

Objectives

To assess the effects of pressure garment therapy (PGT) for preventing abnormal scarring after burn injury.

Methods

Criteria for considering studies for this review

Types of studies

Randomised controlled trials (RCTs).

Types of participants

People of any age or gender with a burn wound, which has acutely healed and has the potential for developing hypertrophic scarring.

Types of interventions

  • Pressure garment therapy (PGT) compared with placebo, no treatment, or another type of scar prevention therapy (for example, surgical, radiation, laser and silicone therapy).

  • Combination therapy PGT with inserts such as silicone, elastomer, putties) compared with PGT alone.

  • Comparisons of different types of PGT.

Types of outcome measures

The outcomes will be measured at 3 months, 6 months, 8 months and 12 months.

Primary outcomes

  • Scar improvement, as assessed by scar rating scales, including the Vancouver Scar Scale (VSS), or Patient Observer Scar Assessment Scale (POSAS). The assessment scales are valid tools for clinical effects evaluation and assess the vascularity, pliability, height and thickness of the healing wound.

  • Adverse events (e.g. necrosis, blistering, ulceration, partial venous obstruction, skeletal deformity).

Secondary outcomes

  • Pigment (measured by Chromameter).

  • Vascularity (measured using laser‐Doppler flowmetry).

  • Pliability, such as articular range of motion (measured serially with the use of an elastometer).

  • Development of complications (e.g. pain, rashes, itching, skin breakdown, measured on a numbered scale).

  • Cosmetic appearance (cosmesis) as defined by patient opinion (using assessment scales) and physician observations.

  • Patient tolerance, measured by reported side effects and adverse reactions.

  • Preference for different modes of treatment, measured by patient choice after receiving at least two different types of treatment.

  • Compliance, measured by physician and patient report.

Search methods for identification of studies

We will not restrict the search by date, language or publication status.

Electronic searches

We will search the following electronic databases.

  • Cochrane Wounds Group's Specialised Register (most recent version).

  • Cochrane Central Register of Controlled Trials CENTRAL (The Cochrane Library) (latest issue).

  • MEDLINE (Ovid SP) (1950 to most recent date available).

  • EMBASE (Ovid SP) (1980 to most recent date available).

  • CINAHL (EBSCO) (1982 to most recent date available).

  • Chinese Biomedical Literature Database (CBM) (1978 to current).

  • Wan Fang database (1986 to current).

  • China National Knowledge Infrastructure (CNKI) Database (1979 to current).

  • VIP Database (1989 to current).

We will use the following provisional search strategy for CENTRAL:

#1 MeSH descriptor: [Burns] explode all trees #2 (burn or burns or burned or scald*):ti,ab,kw #3 (thermal next injur*):ti,ab,kw #4 MeSH descriptor: [Keloid] explode all trees #5 MeSH descriptor: [Cicatrix, Hypertrophic] explode all trees #6 MeSH descriptor: [Hypertrophy] explode all trees #7 (keloid* or hypertrophic or cicatrix):ti,ab,kw #8 (scar or scars or scarred or scarring):ti,ab,kw #9 #1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 #10 MeSH descriptor: [Stockings, Compression] explode all trees #11 MeSH descriptor: [Occlusive Dressings] explode all trees #12 (compression or bandag* or stocking* or hosiery or wrapp*):ti,ab,kw #13 pressure next garment*:ti,ab,kw #14 #10 or #11 or #12 or #13 #15 #9 and #14

We will adapt this strategy to search Ovid MEDLINE (Appendix 1), Ovid EMBASE and EBSCO CINAHL. We will combine the Ovid MEDLINE search with the Cochrane Highly Sensitive Search Strategy for identifying randomised trials in MEDLINE: sensitivity‐ and precision‐maximising version (2008 revision) (Lefebvre 2011). We will combine the EMBASE search with the Ovid EMBASE filter developed by the UK Cochrane Centre (Lefebvre 2011). We will combine the CINAHL searches with the trial filters developed by the Scottish Intercollegiate Guidelines Network (SIGN 2011).

Chinese databases search strategy

We will search Chinese databases (i.e. CBM, CNKI, VIP database, Wanfang database, and Chinese Clinical Trial Register (ChiCTR)) in Chinese using the key words:

  1. burns;

  2. thermal injury;

  3. pressure garment or custom‐made pressure garment or optimal scar pressure garment; and

  4. 1 and 2 and 3

For each Chinese database, we will modify appropriately the above search strategy. For each drug, there might be several Chinese brand names, which we will also use in searching. In some Chinese databases where MeSH can be used, we will also search MeSH terms of these key words listed above.

We will search the following clinical trials registries.

Searching other resources

We will examine the bibliographies of relevant publications identified by the search for further studies, and we will contact experts in the field. We will also contact relevant companies (for example Technomed Limited, Lymed, Jobskin Limited, etc.) to ask if they have any unpublished data that could be included in our review.

Data collection and analysis

Selection of studies

Two review authors (TX, JL) will independently assess the titles and abstracts of articles identified by the search strategy and set aside irrelevant studies. The same two review authors (TX, JL) will obtain full text copies of potentially eligible studies and assess them against the inclusion criteria. Disagreement will be resolved by consultation with a third review author (XHJ). We will complete a PRISMA (Preferred Reporting Items for Systematic Reviews and Meta‐Analyses) flow chart to summarise this process (Liberati 2009).

Data extraction and management

Two review authors (MY, TX) will independently extract data from the included trials using a standardised data extraction form. We will extract data including source of funding, study population, interventions and outcomes. We will resolve any disagreement by referring to a third review author (XHJ). We will contact authors to obtain missing information. YL will check and enter data into Review Manager 5.3 (RevMan 2014) for statistical analysis.

Assessment of risk of bias in included studies

Two review authors (TX, JL) will independently assess the risk of bias of each included trial; the tool for assessing risk of bias is recommended by The Cochrane Collaboration in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011a). We will consider the following domains: random sequence generation; allocation concealment; blinding of participants, personnel and outcome assessment (blind assessment will be made for each main outcome or class of outcome); incomplete outcome data; selective reporting; and any other source of bias.

We will obtain the information from the included study for the judgement of bias, if the information is insufficient, we will write to the original authors for clarification. We will assess overall risk of bias through the assessment of each outcome in each included study. We will assess each outcome as 'low risk of bias', 'high risk of bias', or 'unclear risk of bias'; the criteria for risk of bias judgement is displayed in Appendix 2. We will define each study as having a 'low risk of bias' only if all domains are described as being at low risk of bias; a 'high risk of bias' if one or more domains are described as being at high risk of bias; or 'unclear of bias' if at least one key domain is described as being at 'low risk of bias' without the other domains being described as 'high risk of bias'. We will resolve disagreements by discussion, or consultation with a third review author (XHJ), if necessary.

Measures of treatment effect

Dichotomous data

We will present dichotomous data outcomes as risk ratios (RRs) with 95% confidence intervals (CIs) for individual trials.

Continuous data

We will present continuous data outcomes with mean differences (MDs) and 95% CIs. We will calculate MDs if possible, as these results are easier for clinicians/readers to interpret. We will use standardised mean differences (SMDs) when different scales are used across the trials.

Ordinal data

We will report the types of adverse events and complications in detail if necessary, or treat them as dichotomous/continuous data.

Unit of analysis issues

Unit of analysis issues may arise with studies that include people with multiple burn sites that are treated with the same intervention, and report outcomes for each wound, or with studies in which multiple assessments of an outcome are presented for participants. We will record whether trials presented outcomes in relation to a wound (e.g. burn site), a participant, or as multiple wounds on the same participant. For scar improvement, unless otherwise stated, we will treat the person as the unit of analysis. This situation is similar with cluster randomised trials, and we will attempt to re‐analyse cluster‐randomised trials if they are included in the analysis, by calculating their sample size with an estimate of the intra‐cluster coefficient (ICC), which we will estimate externally from similar studies (Higgins 2011b).

Dealing with missing data

We will contact the trial authors for more information if data are missing from the included studies. If there is no response, we will extract and analyse the available data from the published reports. For dichotomous outcomes, we will carry out an analysis on an intention‐to‐treat basis, using the number randomised as the denominator, and assuming that any participants missing at the endpoint have a negative outcome. We will explore the impact of this assumption by sensitivity analysis. If standard errors are reported and not standard deviations we will compute these.

Assessment of heterogeneity

We will first assess studies on their clinical heterogeneity with respect to the type of therapy (i.e. using custom‐made pressure garments or optimal scar pressure garments), the comparison intervention (i.e. no treatment or alternative therapy), the duration of PGT (i.e. daily use, length of time for PGT prescribed), and the outcomes (i.e. timing of outcomes) in the included studies. We will not combine data from clinically heterogeneous trials in the analysis, but we will describe them separately in our report.

We will test statistical heterogeneity with the Chi2 and I2 statistics. The Chi2 test with a P value < 0.1 indicates significant heterogeneity. We will use I2 statistics in order to quantify heterogeneity across studies, with a rough guide to interpretation as follows: 0% to 40%: might not be important; 30% to 60%: may represent moderate heterogeneity; 50% to 90%: may represent substantial heterogeneity; and 75% to 100%: considerable heterogeneity (Deeks 2011).

Assessment of reporting biases

We will use funnel plots to assess reporting biases when there are at least 10 studies available for the meta‐analysis (Sterne 2011).

Data synthesis

Details of included studies will be combined in narrative review according to the comparison between intervention and comparator, the population and the time point of the outcome measurement. Clinical and methodological heterogeneity will be considered and pooling undertaken when studies appear appropriately similar in terms of intervention type, duration of treatment and outcome assessment.

Subgroup analysis and investigation of heterogeneity

We will pool outcomes from studies with clinical homogeneity by using the fixed‐effect model for meta‐analysis, and we will report results qualitatively if heterogeneity is significant (I2 > 50%). We will use a different statistical model e.g. a random‐effects model instead of a fixed‐effect model when the I2 value is close to 50%.

Sensitivity analysis

We will undertake sensitivity analyses to explore the influence of the following items if an adequate number of studies are identified.

  1. We will assess the effect of included studies with high or unclear risk of bias (Appendix 2), and exclude these trials in the sensitivity analysis. The trials which are defined as at high risk of bias or unclear risk of bias overall will be those trials that are at high or unclear risk of bias in three key domains (random sequence generation, allocation concealment, blinded outcome assessment).

  2. We will assess the effect of included studies with high rate of missing data (> 20%), and exclude these trials in the sensitivity analysis.

  3. We will assess the impact of imputation of missing data in sensitivity analysis without imputation.

Summary of Findings Table

We will present the main results of the review in 'Summary of findings' tables. These tables present key information concerning the quality of the evidence, the magnitude of the effects of the interventions examined and the sum of available data for the main outcomes (Schunemann 2011a). The 'Summary of findings' tables also include an overall grading of the evidence related to each of the main outcomes using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach. The GRADE approach defines the quality of a body of evidence as the extent to which one can be confident that an estimate of effect or association is close to the true quantity of specific interest. The quality of a body of evidence involves consideration of within‐trial risk of bias (methodological quality), directness of evidence, heterogeneity, precision of effect estimates and risk of publication bias (Schunemann 2011b). We plan to present the following outcomes in the 'Summary of findings' tables:

  • Scar improvement

  • Adverse events.

Acknowledgements

The authors would like to acknowledge the contribution of the referees (Ruth Foxlee, Catriona McDaid, Richard Kirubakaran, Mary Mondozzi and Emily O'Halloran) and Cochrane Wounds Group Editor (Sonya Osborne) and the comments of the Copy Editor, Clare Dooley.

Appendices

Appendix 1. Medline (Ovid SP) search strategy

#1 MeSH descriptor Keloid explode all trees #2 MeSH descriptor Cicatrix, Hypertrophic explode all trees #3 (keloid* or hypertrophic or cicatrix):ti,ab,kw #4 (scar or scars or scarred or scarring):ti,ab,kw #5 MeSH descriptor Burns explode all trees #6 (burn or burns or burned):ti,ab,kw #7 (#1 OR #2 OR #3 OR #4 OR #5 OR #6) #8 pressure NEXT garment*:ti,ab,kw #9 MeSH descriptor Pressure explode all trees #10 MeSH descriptor Stockings, Compression explode all trees #11 stocking* or hosiery:ti,ab,kw #12 tubigrip or tubi grip or JOBST:ti,ab,kw #13 (#8 OR #9 OR #10 OR #11 OR #12) #14 (#7 AND #13)

Appendix 2. Criteria of risk of bias judgement for RCTs

1. Random sequence generation

Low risk of bias

The investigators describe a random component in sequence generation process such as: referring to a random number table; using a computer random number table; coin tossing; shuffling cards or envelopes; throwing dice; drawing of lots; minimisation.

High risk of bias

The investigators describe a non‐random component in the sequence generation. Usually, it could be described such as: sequence generated by odd or even date of birth; sequence generated by some rule based on the date (or day) of admission; sequence generated by some rule based on hospital or clinic record number.

Unclear risk of bias

Insufficient information about the sequence generation process to permit judgement of 'low risk' or 'high risk'.

2. Adequate allocation concealment

Low risk of bias

Participants and investigators enrolling participants could not foresee assignment because one of the following, or an equivalent method, was used to conceal allocation: central allocation (including telephone, web‐based and pharmacy‐controlled randomisation); sequentially numbered drug containers of identical appearance; sequentially numbered, opaque, sealed envelopes.

High risk of bias

Participants or investigators enrolling participants could possibly foresee assignments and thus introduce selection bias, such as allocation based on: using an open random allocation schedule, e.g. a list of random numbers; assignment envelopes were used without appropriate safeguards, e.g. if envelopes were unsealed or non‐opaque or not sequentially numbered; alternation or rotation; date of birth; case record number; any other explicitly unconcealed procedure.

Unclear risk of bias

Insufficient information to permit judgement of 'low risk' or 'high risk'. This is usually the case if the method of concealment is not described or not described in sufficient detail to allow a definite judgement – for example, if the use of assignment envelopes is described, but it remains unclear whether envelopes were sequentially numbered, opaque and sealed.

3. Blinding of the allocation of interventions by participants and personnel during the study

Low risk of bias

Any one of the following.

  • No blinding or incomplete blinding, but the review authors judge that the outcome is not likely to be influenced by lack of blinding.

  • Blinding of participants and key study personnel ensured, and unlikely that the blinding could have been broken.

High risk of bias

Any one of the following.

  • No blinding or incomplete blinding, and the outcome is likely to be influenced by lack of blinding.

  • Blinding of key study participants and personnel attempted, but likely that the blinding could have been broken, and the outcome is likely to be influenced by lack of blinding.

Unclear risk of bias

Any one of the following.

  • Insufficient information to permit judgement of 'low risk' or 'high risk'.

  • The study did not address this outcome.

4. Blinding of the outcome assessors to the allocation of the intervention.

Low risk of bias

Any one of the following.

  • No blinding of outcome assessment, but the review authors judge that the outcome measurement is not likely to be influenced by lack of blinding.

  • Blinding of outcome assessment ensured, and unlikely that the blinding could have been broken.

High risk of bias

Any one of the following.

  • No blinding of outcome assessment, and the outcome measurement is likely to be influenced by lack of blinding.

  • Blinding of outcome assessment, but likely that the blinding could have been broken, and the outcome measurement is likely to be influenced by lack of blinding.

Unclear risk of bias

Any one of the following.

  • Insufficient information to permit judgement of 'low risk' or 'high risk'.

  • The study did not address this outcome.

5. Incomplete outcome data adequately addressed

Low risk of bias

Any one of the following.

  • No missing outcome data.

  • Reasons for missing outcome data unlikely to be related to true outcome (for survival data, censoring unlikely to be introducing bias).

  • Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups.

  • For dichotomous outcome data, the proportion of missing outcomes compared with observed event risk not enough to have a clinically relevant impact on the intervention effect estimate.

  • For continuous outcome data, plausible effect size (difference in means or standardised difference in means) among missing outcomes not enough to have a clinically relevant impact on observed effect size.

  • Missing data have been imputed using appropriate methods.

High risk of bias

Any one of the following.

  • Reason for missing outcome data likely to be related to true outcome, with either imbalance in numbers or reasons for missing data across intervention groups.

  • For dichotomous outcome data, the proportion of missing outcomes compared with observed event risk enough to induce clinically relevant bias in intervention effect estimate.

  • For continuous outcome data, plausible effect size (difference in means or standardised difference in means) among missing outcomes enough to induce clinically relevant bias in observed effect size.

  • "As‐treated" analysis done with substantial departure of the intervention received from that assigned at randomisation.

  • Potentially inappropriate application of simple imputation.

Unclear risk of bias

Any one of the following.

  • Insufficient reporting of attrition/exclusions to permit judgement of 'low risk' or 'high risk' (e.g. number randomised not stated, no reasons for missing data provided).

  • The study did not address this outcome.

6. Study report free of selective outcome reporting

Low risk of bias

Any of the following.

  • The study protocol is available and all of the study's prespecified (primary and secondary) outcomes that are of interest in the review have been reported in the prespecified way.

  • The study protocol is not available, but it is clear that the published reports include all expected outcomes, including those that were prespecified (convincing text of this nature may be uncommon).

High risk of bias

Any one of the following.

  • Not all of the study's prespecified primary outcomes have been reported.

  • One or more primary outcomes is reported using measurements, analysis methods or subsets of the data (e.g. subscales) that were not prespecified.

  • One or more reported primary outcomes were not prespecified (unless clear justification for their reporting is provided, such as an unexpected adverse effect).

  • One or more outcomes of interest in the review are reported incompletely so that they cannot be entered in a meta‐analysis.

  • The study report fails to include results for a key outcome that would be expected to have been reported for such a study.

Unclear risk of bias

Insufficient information to permit judgement of 'low risk' or 'high risk'. It is likely that the majority of studies will fall into this category.

7. Other source of bias

Low risk of bias

The study appears to be free of other sources of bias.

High risk of bias

There is at least one important risk of bias. For example, the study:

  • had a potential source of bias related to the specific study design used; or

  • has been claimed to have been fraudulent; or

  • had some other problem.

Unclear risk of bias

There may be a risk of bias, but there is either:

  • insufficient information to assess whether an important risk of bias exists; or

  • insufficient rationale or evidence that an identified problem will introduce bias.

What's new

Date Event Description
6 April 2017 Amended This protocol has been withdrawn as authors were unable to progress the review.
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Contributions of authors

Ting Xu: Developed and co‐ordinated the protocol. Completed the first draft of the protocol and edited subsequent drafts. Approved the final version of the protocol prior to submission. Jing Lu: Performed part of the writing and editing of the protocol. Made an intellectual contribution to the protocol and advised on part of the protocol. Ming Yang, Xuehua Jiang: Edited and advised on the protocol. Made an intellectual contribution to the protocol. Yong Liu: Advised on part of the protocol and provided clinical knowledge. Made an intellectual contribution to the protocol.

Contributions of editorial base:

Editor Joan Webster: edited the protocol; advised on methodology and content. Approved the final protocol prior to submission. Sally Bell‐Syer: coordinated the editorial process. Advised on methodology, interpretation and content. Edited the protocol. Amanda Briant: designed the search strategy and edited the search methods section.

Sources of support

Internal sources

  • No sources of support supplied

External sources

  • This project was supported by the National Institute for Health Research, via Cochrane Infrastructure, Cochrane Programme Grant or Cochrane Incentive funding to Cochrane Wounds. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or the Department of Health, UK.

Declarations of interest

Ting Xu: none known. Jing Lu: none known. Ming Yang: none known. Xuehua Jiang: none known. Yong Liu: none known.

Notes

This protocol has been withdrawn as authors were unable to progress the review.

Withdrawn from publication for reasons stated in the review

References

Additional references

  1. Anzarut A, Olson J, Singh P, Rowe BH, Tredget EE. The effectiveness of pressure garment therapy for the prevention of abnormal scarring after burn injury: a meta‐analysis. Journal of Plastic, Reconstructive and Aesthetic Surgery 2009;62(1):77‐84. [DOI] [PubMed] [Google Scholar]
  2. Brown CA. A comparison of the outcomes of two clinical audits of burn pressure garment satisfaction and compliance in Saudi Arabia. Burns 2001;27(4):342‐8. [DOI] [PubMed] [Google Scholar]
  3. Carr‐Collins JA. Pressure techniques for the prevention of hypertrophic scars. Clinics in Plastic Surgery 1992;19(3):733‐43. [PubMed] [Google Scholar]
  4. Deeks JJ, Higgins JPT, Altman DG (editors). Chapter 9: Analysing data and undertaking meta‐analyses. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane‐handbook.org.
  5. Eberlein A, Perbix W, Spilker G. Kompressionstherapie bei Brandverletzten. Orthopadie‐Technik 2004;55:284‐97. [Google Scholar]
  6. Endorf FW, Ahrenholz D. Burn management. Current Opinion in Critical Care 2011;17(6):601‐5. [DOI] [PubMed] [Google Scholar]
  7. Engrav LH, Heimbach DM, Rivara FP. 12‐year within‐wound study of the effectiveness of custom pressure garment therapy. Burns 2010;36(7):975‐83. [DOI] [PubMed] [Google Scholar]
  8. Esselman PC, Thoms BD, Magyar‐Russell G, Fauerbach JA. Burn rehabilitation: state of the science. American Journal of Physical Medicine and Rehabilitation 2006;85(4):383‐413. [DOI] [PubMed] [Google Scholar]
  9. Fricke NB, Omnell ML, Dutcher KA. Skeletal and dental disturbances in children after facial burns and pressure garment use: a 4‐year follow‐up. Journal of Burn Care and Rehabilitation 1999;20(3):239‐49. [DOI] [PubMed] [Google Scholar]
  10. Herndon DN. Total Burn Care. 4th Edition. Elsevier Health Sciences, 2010. [Google Scholar]
  11. Higgins JPT, Altman DG, Sterne JAC (editors). Chapter 8: Assessing risk of bias in included studies. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane‐handbook.org.
  12. Higgins JPT, Deeks JJ, Altman DG (editors). Chapter 16: Special topics in statistics. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane‐handbook.org.
  13. Hubbard M, Masters IB, Williams GR, Chang AB. Severe obstructive sleep apnoea secondary to pressure garments used in the treatment of hypertrophic burn scars. European Respiratory Journal 2000;16(6):1205‐7. [DOI] [PubMed] [Google Scholar]
  14. Johnson J, Greenspan B, Gorga D, Nagler W, Goodwin C. Compliance with pressure garment use in burn rehabilitation. Journal of Burn Care and Rehabilitation 1994;15(2):180‐8. [DOI] [PubMed] [Google Scholar]
  15. Juckett G,  Hartman‐Adams H. Management of keloids and hypertrophic scars. American Family Physician 2009;80(3):253‐60. [PubMed] [Google Scholar]
  16. Judge JC, May SR, DeClement FA. Control of hypertrophic scarring in burn patients using tubular support bandages. Journal of Burn Care and Rehabilitation 1984;5(3):221‐4. [Google Scholar]
  17. Lefebvre C, Manheimer E, Glanville J. Chapter 6: Searching for studies. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane‐handbook.org.
  18. Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gotzsche PC, Ioannidis JP, et al. The PRISMA statement for reporting systematic reviews and meta‐analyses of studies that evaluate health care interventions: explanation and elaboration. PLoS Medicine 2009;6(7):e1000100. [DOI] [PMC free article] [PubMed] [Google Scholar]
  19. Linares H, Larson D, Willis‐Galstaun B. Historical notes on the use of pressure in the treatment of hypertrophic scars or keloids. Burns 1993;19(1):17‐21. [DOI] [PubMed] [Google Scholar]
  20. NG SF. Design of Pressure Garments for Hypertrophic Scar Treatment [PhD thesis]. Leicester: De Montfort University, 1995. [Google Scholar]
  21. Yildiz N. A novel technique to determine pressure in pressure garments for hypertrophic burn scars and comfort properties. Burns 2007;33(1):59‐64. [DOI] [PubMed] [Google Scholar]
  22. Peck MD. Epidemiology of burns throughout the world. Part I: Distribution and risk factors. Burns 2011;37(7):1087‐100. [DOI] [PubMed] [Google Scholar]
  23. Puzey G. The use of pressure garments on hypertrophic scars. Journal of Tissue Viability 2002;12(1):11‐5. [DOI] [PubMed] [Google Scholar]
  24. Reid WH, Evans JH, Naismith RS, Tully AE, Sherwin S. Hypertrophic scarring and pressure therapy. Burns, Including Thermal Injury 1987;13 Suppl:S29–32. [DOI] [PubMed] [Google Scholar]
  25. Reno F, Grazianetti P, Cannas M. Effects of mechanical compression on hypertrophic scars: prostaglandin E2 release. Burns 2001;27(3):215‐8. [DOI] [PubMed] [Google Scholar]
  26. The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 5.3. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014.
  27. Ripper S, Renneberg B, Landmann C, Weigel G, Germann G. Adherence to pressure garment therapy in adult burn patients. Burns 2009;35(5):657‐64. [DOI] [PubMed] [Google Scholar]
  28. Sawada Y. A method of recording and objective assessment of hypertrophic burn scars. Burns 1994;20(1):76‐8. [DOI] [PubMed] [Google Scholar]
  29. Schünemann HJ, Oxman AD, Higgins JPT, Vist GE, Glasziou P, Guyatt GH. Chapter 11: Presenting results and 'Summary of findings' tables. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. www.cochrane‐handbook.org.
  30. Schünemann HJ, Oxman AD, Higgins JPT, Deeks JJ, Glasziou P, Guyatt GH. Chapter 12: Interpreting results and drawing conclusions. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. www.cochrane‐handbook.org.
  31. Scottish Intercollegiate Guidelines Network (SIGN). Search Filters. http://www.sign.ac.uk/methodology/filters.html#random.
  32. Spilker G, Tolksdorf‐Kremmer A, Küppers S. Kompressionstherapie [Compression therapy]. In: Bruck JC, Müller FE, Steen M editor(s). Handbuch der Verbrennungstherapie. 1st Edition. Landsberg: Ecomed, 2002. [Google Scholar]
  33. Staley MJ, Richard RL. Use of pressure to treat hypertrophic burn scars. Advances in Wound Care 1997;10(3):44‐6. [PubMed] [Google Scholar]
  34. Sterne JAC, Egger M, Moher D (editors). Chapter 10: Addressing reporting biases. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Intervention Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane‐handbook.org.
  35. Stewart R, Bhagwanjee AM, Mbakaza Y, Binase T. Pressure garment adherence in adult patients with burn injuries, an analysis of patient and clinician perceptions. The American Journal of Occupational Therapy 2000;54(6):598‐606. [DOI] [PubMed] [Google Scholar]
  36. Tsao SS, Dover JS, Arndt KA, Kaminer MS. Scar management: keloid, hypertrophic, atrophic, and acne scars. Seminars in Cutaneous Medicine and Surgery 2002;21(1):47‐75. [DOI] [PubMed] [Google Scholar]
  37. Tuan TL, Nichter LS. The molecular basis of keloid and hypertrophic scar formation. Molecular Medicine Today 1998;4(1):19‐24. [DOI] [PubMed] [Google Scholar]
  38. Tyack Z, Simons M, Spinks A. A systematic review of the quality of burn scar rating scales for clinical and research use. Burns 2012;38(1):6‐18. [DOI] [PubMed] [Google Scholar]
  39. Urioste SS, Arndt KA, Dover JS. Keloids and hypertrophic scars: review and treatment strategies. Seminars in Cutaneous Medicine and Surgery 1999;18(2):159‐71. [DOI] [PubMed] [Google Scholar]
  40. Ward RS, Hayes‐Lundy C, Reddy R, Brockway C, Mills P. Influence of pressure supports on joint range of motion. Burns 1992;18(1):60‐2. [DOI] [PubMed] [Google Scholar]
  41. Williams F, Knapp D, Wallen M. Comparison of the characteristics and features of pressure garments used in the management of burn scars. Burns 1998;24(4):329‐35. [DOI] [PubMed] [Google Scholar]

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