Prospective, Randomized Study of the Efficacy of Pressure Garment Therapy in Patients With Burns

Chang, Phyllis; Laubenthal, K N; Lewis, Robert W.; Rosenquist, Magnus; Lindley-Smith, P; Kealey, Gerald P.

doi:10.1097/00004630-199509000-00002

Cited by 84 publications

(39 citation statements)

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“…The clinical outcome of the two groups was comparable, with significantly greater adherence and lower cost in the Tubigrip arm of the trial. In 1995, Chang et al 26 randomised 122 patients, who required either skin grafting or their wounds to be healed over a period > 2 weeks, to either PGT or no PGT. The two groups were matched for age, percentage of total body surface area (TBSA) burned and length of hospital stay.…”

Section: Evidence Of the Effectiveness And Efficacy Of Pressure Garmementioning

confidence: 99%

Pressure garment to prevent abnormal scarring after burn injury in adults and children: the PEGASUS feasibility RCT and mixed-methods study

Moiemen

Mathers

Jones

et al. 2018

Health Technol Assess

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Background Eleven million people suffer a fire-related injury worldwide every year, and 71% have significant scarring. Pressure garment therapy (PGT) is a standard part of burn scar management, but there is little evidence of its clinical effectiveness or cost-effectiveness. Objective To identify the barriers to, and the facilitators of, conducting a randomised controlled trial (RCT) of burn scar management with and without PGT and test whether or not such a trial is feasible. Design Web-based surveys, semistructured individual interviews, a pilot RCT including a health economic evaluation and embedded process evaluation. Setting UK NHS burns services. Interviews and the pilot trial were run in seven burns services. Participants Thirty NHS burns services and 245 staff provided survey responses and 15 staff participated in individual interviews. Face-to-face interviews were held with 24 adult patients and 16 parents of paediatric patients who had undergone PGT. The pilot trial recruited 88 participants (57 adults and 31 children) who were at risk of hypertrophic scarring and were considered suitable for scar management therapy. Interviews were held with 34 participants soon after recruitment, with 23 participants at 12 months and with eight staff from six sites at the end of the trial. Interventions The intervention was standard care with pressure garments. The control was standard care comprising scar management techniques involving demonstration and recommendations to undertake massage three or four times per day with moisturiser, silicone treatment, stretching and other exercises. Main outcome measures Feasibility was assessed by eligibility rates, consent rates, retention in allocated arms, adherence with treatment and follow-up and completion of outcome assessments. The outcomes from interview-based studies were core outcome domains and barriers to, and facilitators of, trial participation and delivery. Results NHS burns services treat 2845 patients per annum (1476 paediatric and 1369 adult) and use pressure garments for 6–18 months, costing £2,171,184. The majority of staff perceived a need for a RCT of PGT, but often lacked equipoise around the research question and PGT as a treatment. Strong views about the use of PGT have the potential to influence the conduct of a full-scale RCT. A range of outcome domains was identified as important via the qualitative research: perceptions of appearance, specific scar characteristics, function, pain and itch, broader psychosocial outcomes and treatment burden. The outcome tools evaluated in the pilot trial did not cover all of these domains. The planned 88 participants were recruited: the eligibility rate was 88% [95% confidence interval (CI) 83% to 92%], the consent rate was 47% (95% CI 40% to 55%). Five (6%) participants withdrew, 14 (16%) were lost to follow-up and 8 (9%) crossed over. Adherence was as in clinical practice. Completion of outcomes was high for adult patients but poorer from parents of paediatric patients, particularly for quality of life. Sections on range of movement and willingness to pay were found to be challenging and poorly completed. Limitations The Brisbane Burn Scar Impact Profile appears more suitable in terms of conceptual coverage than the outcome scales that were used in the trial but was not available at the time of the study. Conclusions A definitive RCT of PGT in burn scar management appears feasible. However, staff attitudes to the use of pressure garments may lead to biases, and the provision of training and support to sites and an ongoing assessment of trial processes are required. Future work We recommend that any future trial include an in-depth mixed-methods recruitment investigation and a process evaluation to account for this. Trial registration Current Controlled Trials ISRCTN34483199. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 36. See the NIHR Journals Library website for further project information

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Section: Evidence Of the Effectiveness And Efficacy Of Pressure Garmementioning

confidence: 99%

Pressure garment to prevent abnormal scarring after burn injury in adults and children: the PEGASUS feasibility RCT and mixed-methods study

Moiemen

Mathers

Jones

et al. 2018

Health Technol Assess

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“…There is, however, evidence regarding the use of much higher pressure garments (15 to 30mmHg) for the purpose of treating hypertrophic scarring on burn scars and grafts. However, those higher pressures were applied to burn wounds and grafts at a later stage of healing (Macintyre & Baird, 2006;Li-Tsang et al, 2015;Yildiz, 2007;Ripper et al, 2009;Bloemen et al, 2009;Chang et al, 1995;Anzarut et al, 2009;Gladfelter, 2007) and on deeper wounds than donor sites thus the findings cannot be extrapolated to donor site wounds. It is well documented that wounds healing under tension are associated with thicker scarring (Widgerow et al, 2010).…”

Section: Resultsmentioning

confidence: 99%

“…Pressure garment therapy has been used for over 40 years to reduce thickened burns scars and graft sites (Ripper et al, 2009;Bloemen et al, 2009;Macintyre, 2006;Anzarut et al, 2009;Chang, et al, 1995;Gladfelter, 2007;Watkins, 2010. ) Pressure is applied to the healed burn scar or graft with a firm elastic garment, and dissipates the intrinsic tension in the wound, consequently reducing the amount of scar tissue generated (Larson et al, 1971cited in Harrison, 2008.…”

Section: Pressure Garment Therapymentioning

confidence: 99%

“…This process of scar maturation is reported to take 18 to 24 months to complete, but can be longer in some cases (Quinn et al, 2010;Demirtas et al, 2010;Bloemen et al, 2009;Chang et al, 1995;Watkins, 2010).…”

Section: Pressure Garment Therapymentioning

confidence: 99%

“…Although it is a well-known treatment in reducing scar formation following a burn, the effectiveness of pressure has not been scientifically assessed on donor site scars (Quinn et al, 2010;Demirtas et al, 2006;Ripper et al, 2009;Macintyre, 2006;Anzarut et al, 2009;Chang et al, 1995;Gladfelter, 2007;Watkins, 2010;Partsch & Mosti, 2008).…”

Section: Pressure Garment Therapymentioning

confidence: 99%

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Interim pressure garment therapy: an investigation into the use of low level pressure therapy for burns donor site support and scar management

Donovan¹

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Split Thickness Skin Grafting (STSG) is a well-known and established procedure for healing burn wounds throughout the world. The procedure requires the removal of the epidermal and part of the dermal layer of the skin. It leaves intact the deep reticular dermal layer which is known as the donor site, and has sufficient cells to regenerate the excised superficial layers. STSG provides wound closure and accelerated healing for the burn wound, and there is great importance surrounding the success of graft take and scar management thereafter (Demirtas et al, 2009; Atiyeh et al, 2002). The presence of donor sites, though created to assist healing of the burn site, in fact creates an additional wound for the patient which often causes further psychological stress at a traumatic time in the healing process (Andrews, Brown, Drummond, & Wood, 2010). Donor sites are consistently identified as a particularly painful wound by burn patients. Pain associated with burn surgery has been shown to delay the patients return to work and daily functional activity (Wisley et al, 2010; Druery et al, 2005; Brown et al, 2008). Thus, protection of the remaining epidermal and dermal elements of this surgical wound (donor site) is required to assist effective tissue healing with minimal scarring. One intervention that may accelerate healing and reduce scar formation is the use of Interim Pressure Garment Therapy (IPGT) which applies 4-6mmHg of pressure to the thigh. This treatment has been utilised at a major Australian burns unit in Queensland by Occupational Therapists. However, this has involved inconsistent application with a focus on securing wound dressing rather than scar management. Despite this, anecdotal and observational evidence suggests that pressure therapy also makes a difference to some patient's scar outcomes for donor sites. It is hypothesised that IPGT may improve postoperative management of donor sites through the application of a low superficial pressure that mimics normal skin tension, possibly preventing donor wound distension and subsequent micro-tears in the newly forming epidermis. Furthermore, this may reduce the effects of the inflammatory response, which may in turn give rise to a hypertrophic scar response in the later stages of the healing process. This research focuses on a unique area of burns donor site scar management. It is designed to test a low pressure tubular support garment as an intervention for the support of, and reduction of donor site scarring. No known studies of this nature have been carried out to date, suggesting there is a need for rigorous clinical evidence to support the use of these garments for donor site scar minimisation. Thereby, two studies were undertaken. The objective of the first study was to determine the pressure range (mmHg) applied by the Interim Pressure Garment Therapy (IPGT). Forty seven healthy adult volunteers were measured and fitted with a pair of Interim Pressure Garments (IPG). s33634065 ii | P a g e The garments were made onsite from a tubular knit material, simil...

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Dressings for superficial and partial thickness burns

Wasiak¹,

Cleland²,

Campbell³

2008

Cochrane Database of Systematic Reviews

136

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Prospective, Randomized Study of the Efficacy of Pressure Garment Therapy in Patients With Burns

Cited by 84 publications

References 0 publications

Pressure garment to prevent abnormal scarring after burn injury in adults and children: the PEGASUS feasibility RCT and mixed-methods study

Pressure garment to prevent abnormal scarring after burn injury in adults and children: the PEGASUS feasibility RCT and mixed-methods study

Interim pressure garment therapy: an investigation into the use of low level pressure therapy for burns donor site support and scar management

Dressings for superficial and partial thickness burns

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