Evaluating Pressure Garment Therapy as a Treatment Modality for Burn Scar Management

The authors of this review selected eight studies that were published between 1995 and 2018. The objective of this study was to investigate available evidence on the effectiveness of Pressure Garment Therapy (PGT) in treating post-burn scar management. The prevalence of burn injuries is far greater than is often recognized, with approximately 180,000 deaths occurring each year due to burn injuries (World Health Organization, 2018). Burn injuries can be caused by heat or radiation from exposure to hot liquids, hot solids, flames, chemicals, or electricity (WHO, 2018). Exposure to any form of heat may result in thermal burns—ranging between scalds, contact burns, and flame burns—which can destroy some or all of one’s skin cells or other tissues (WHO, 2018). A widespread modality of treatment for burn injuries is PGT, which uses compression garments to apply specific pressure grades to burn scars over an extended period of time (Atiyeh, El Khatib, & Dibo, 2013). Pressure Garment Therapy is particularly effective in treating post-burn hypertrophic scars, which are considered “a systemic inflammatory illness regulated by local wound healing factors” (Atiyeh et al., 2013, p. 206). Hypertrophic scarring can be particularly problematic for individuals who have either delayed healing or areas with skin grafting (Atiyeh et al., 2013). Consequently, healthcare practitioners resort to PGT for treating hypertrophic scars despite its lack of support in literature. Pressure garment therapy is a highly regimented mode of treatment with limited research available to suggest its efficacy; thus, PGT has been evaluated alongside other modalities in order to identify its efficacy as a stand-alone treatment.

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Van den Kerckhove et al. (2005) conducted a prospective, randomized controlled study from September 1999 to June 2002 in Belgium. A total of 60 patients with a mean age of 37.5 years were included in the study, and 76 total forearm or calf scars were analyzed to assess the effectiveness of PGT as a preventative measure for hypertrophic scarring. Two weeks after wound reepithelialisation, patients were randomly assigned to either normal or lower compression groups and began PGT. The normal compression group started with a mean pressure of 20 mmHg, while the lower compression group started with a mean pressure of 12 mmHg. All patients were instructed to wear the pressure garments for 23 hours a day for the entirety of the three-month treatment period. The researcher took measurements once a month with a chromameter to assess erythema and a high frequency ultrasonography to measure the thickness of the scars.

 First, a Wilcox test was used to measure the amount of pressure lost by the garments worn in both groups. The results found that the normal compression group lost the most pressure over the one month period. These findings suggest the difficulty of maintaining a constant, measured pressure dosage throughout PGT periods. Then, a Spearman correlation test was used to analyze the relationship between erythema and thickness, and a regression model was used to assess the change in both thickness and erythema. A significant difference was found in the thickness and scar decay when comparing pre and post treatment data; moreover, the normal compression group was found to be most effective when evaluating scar thickness. The results also found a significant correlation between erythema and thickness in post-burn scars. However, the researchers in this study did not find a statistically significant effect on erythema between the normal and lower compression groups. Instead, Van den Kerckhove et al. (2005) hypothesized that the garments’ pressure needs to be higher than capillary pressure in order for PGT to be effective in reducing scar thickness and erythema. 

Li et al. (2018) examined the recovery of post-burn hypertrophic scarring over time during a monitored pressure therapy intervention program by assessing scars according to who received early pressure intervention (e.g., within 60 days of injury) and who received late pressure intervention (e.g., after 61 days of injury). This longitudinal cohort design study included 34 subjects from a hospital in Chengdu, China. The selected patients were retrospectively placed into the early intervention group or late intervention group depending on when they first arrived in the hospital. A total of 65 post-burn hypertrophic scars were treated in a six-month pressure therapy program that used pressure garments designed by Smart Pressure Monitored Suits (SPMS). Pressure was delivered at 10-15mmHg and the garments were to be worn for 23 hours a day. Monthly assessments of scar pigmentation were conducted using a MiniScan XE Spectrocolorimeter. Similarly, scar thickness was assessed using a Terason t3000 portable ultrasound. Next, scar pliability, vascularity, pigmentation, and height were collectively evaluated using the Vancouver Scar Scale (VSS). Finally, subjects’ self-reported pain and itch were recorded using the Visual Analogue Scale on Pain and Itch (VAS).

Data analysis was completed through the use of SPSS. Specifically, the Mann-Whitney U test and Fisher Exact test were used to analyze group differences; paired t-tests and Wilcoxon signed ranks tests were used to analyze scar differences; ANOVA, independent t-tests, and paired t-tests were used to address both scar pigmentation and thickness; and the last-observation-carried-forward method was used to account for any missing data. The results found that the early intervention group demonstrated significant improvement in scar pigmentation, thickness, VSS scores, and scores of pain and itch. Similarly, the late intervention group found significant improvement in scar lightness, yellowness, VSS scores, and scores of pain and itch. Nonetheless, the early intervention group demonstrated greater improvements in scar pigmentation, thickness, and pain scores when compared to the late intervention group. Even at similar times in scar maturation, the scars of the early intervention group had lower itch and pain scores when compared to the late intervention group. Thus, Li et al. (2018) suggests that regulated pressure therapy may improve scar management when applied within two months of initial injury (e.g., early intervention).

Using a randomized, double-blinded, controlled clinical trial, Li-Tsang, Zheng, and Lau (2010) studied the effects of PGT, silicone gel sheeting, and a combination of the two for the management of posttraumatic hypertrophic scars in 104 subjects. Participants were recruited from Jiangsu People’s First Affiliated Hospital in Nanjing, China and then randomly assigned into 4 groups: a PGT group, a silicone gel sheeting group, a combined PGT and silicone gel sheeting group, and a single-blinded control group with no treatment. The raters of the study were blinded to the subjects’ intervention. Standardized assessments were completed prior to the start of the study and at two, four, and six month intervals as treatment was administered; a final assessment was completed one month after the study. The assessments analyzed scar vascularity, pigmentation, thickness, pain, and itchiness. Specifically, a spectrocolorimeter was used to test scar color (e.g., yellowness, lightness, redness); the Tissue Ultrasound Palpation System (TUPS) was used to measure the scar thickness; the Vancouver Scar Scale (VSS) was used to measure the scar pliability; and the Visual Analog Scale (VAS) was used to allow subjects to report pain and itchiness of scars.

Data analysis was conducted using SPSS. Tukey’s post hoc comparison analysis observed the differences between the groups and a Bonferroni correction was used to adjust the significance level to reduce potential for type I errors. The results showed that all treatments had positive effects on the scars when compared to the control group. After six months of treatment, both the PGT group and the combined pressure and silicone gel therapy group showed improvements in scar thickness, with more significant improvements seen in the combined pressure and silicone gel group. However, the silicone gel therapy group was found to be most effective in alleviating pain and pruritus, while the combined group seemed to be more effective for scar reduction, thickness, pliability, and pigmentation. Therefore, Li-Tsang et al. (2010) suggests that using PGT to treat post-burn hypertrophic scars can improve overall scar management, and perhaps even greater results can be observed when PGT is used in combination with silicone gel therapy.

In 2011, Steinstraesser et al. conducted a prospective, within-subject comparison, randomized controlled trial that assessed treatment modalities for hypertrophic scarring in 43 total participants with comparable burns. Eligible participants were at least 18 years of age and required a Fitzpatrick skin type ranging from one to three as well as two comparable split skin grafted burn areas. Although participants were non-randomly selected, they were randomly assigned to either of the two treatment groups: group one using silicone gel sheeting in combination with PGT and group two using self-drying silicone spray in combination with PGT. Both groups also compared the assigned multimodal treatment to PGT alone. Scar treatments were administered for 12 months and scar assessments were conducted for 18 months.

Scar assessment took place once participants were discharged from the hospital during various appointments, including: 1 day, 2 week, 2 month, 6 month, 1 year, and 18 month appointments. At each appointment, measurements of scar differences were taken using chromometry, profilometry , the Vancouver Scar Scale, and photographic documentation.

Data analysis was conducted by the Department for Medical Computer Science in Germany using SPSS. Only 38 total participants were eligible for data analysis, as participants who violated study protocol, failed to follow up, or demonstrated poor compliance were eliminated from analysis. The Mann-Whitney U test was used to assess differences between silicone gel sheeting and silicone spray, whereas the Wilcoxon signed rank test was used to make intraindividual comparisons between PGT alone and multimodal treatments. The results found that multimodal therapy (e.g., silicone gel sheeting and silicone spray combined with PGT) significantly improved the average Vancouver Scar Scale scores. Similarly, PGT alone was found to significantly improve the Vancouver Scar Scale scores. Steinstraesser et al. (2011)’s findings suggest that multimodal therapies are not always more effective than PGT alone when treating hypertrophic scarring. Thus, no statistically significant intraindividual differences could be determined by the Vancouver Scar Scale score improvements over the 18 month study period between silicone spray and gel sheeting combined with PGT and PGT alone.

Karimi, Mobayen, and Alijanpour (2012) conducted a prospective study to explore treatment measures for burn-related scaring.  Sixty-six patients were recruited from the burn care center of Tehran University of Medical Sciences. Sixty-four patients participated in follow-ups throughout the study. At the beginning of the study, all patients received PGT; after two weeks, the patients who could no longer tolerate PGT were treated with exercise and physiotherapy. The control group included patients treated with PGT and silicone therapy; although, at first, the control group received physiotherapy until it was discontinued. Instead, the control group followed PGT protocol in the home once discharged from the hospital. The case group included patients treated with exercise and physiotherapy, specifically using: passive joint movements, manual scar massage, and strengthening exercises. Patients completed these exercises in 30 minute sessions in both their homes and two to three times a week in the clinic.

Patients in both groups were regularly visited every four to six weeks for about 20 months to ensure patient compliance and assess scar maturation. The patients’ scar changes were measured using the Vancouver Scar scale. Changes in limb function were assessed by physical examination and joint range of motion was measured by goniometry. The results of the study found physiotherapy and exercise to be more effective in hypertrophic scar management when compared to PGT and silicone therapy. Thus, Karimi et al. (2012) suggests that PGT in combination with other therapies might not be as effective as other, unrecognized treatment modalities for burn scarring, such as physiotherapy and exercise.

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Chang et al. (1995) conducted a randomized prospective study to learn about the effectiveness of pressure garment therapy in 124 patients with burns from the burn treatment center at the University of Iowa. . Patients with either hand or facial burns were not included in this study. Eligible patients required wounds with more than 14 days before the skin would close or wounds that needed skin grafting to close. Wounds, in this case, were considered mature when less than ten percent of the entire wound showed scar hypertrophy or hyperemia. Patients were then randomly assigned to one of two groups: group one (n=66) received PGT and group two (n=58) received no PGT. The Vancouver Scar scale was used to assess the physical parameters of scar pigmentation, height, vascularity, and pliability. The data showed no significant differences in the rate of maturation between group one (e.g., receiving PGT) and group two (e.g., receiving no PGT).  The patients receiving PGT showed a mean time of 266 days for wound maturation, whereas the patients not receiving PGT showed a mean time of 273 days for wound maturation. Results from the Wilcoxon test showed no significant differences between the two groups when comparing the burn surface area, age, and hospital length of stay. Thus, Chang et al. (1995) suggests questionable efficacy of PGT when considering the between group differences found in this study.
 Engrav et al. (2010) conducted a randomized, within-wound comparison study at the University of Washington on 67 patients between 1995 and 2007 to evaluate custom garments in PGT. To establish the effectiveness of PGT, the researchers examined the color, hardness, thickness, and clinical appearance of the scarring after treatment. The custom garments were then analyzed to establish pressure measurements that were being applied to the scars throughout the treatment. Eligible subjects (n=54) required a forearm burn that was measured to be four centimeters in diameter and had been grafted or needed three more weeks to heal. Patients who were considered non-complaint were excluded from this study. During PGT implementation, the researchers followed up with patients for one year; specifically, during five follow-up periods occurring every two to three months. Custom fitted garments were created for each patient and designed to apply random pressures to either the proximal zone or distal zone of the wound; pressure in the normal compression zone was between 17-24 mmHg and pressure in the low compression zone was less than 5 mmHg. Patients were to wear the custom garment for 23 hours a day and to record their self-reported compliance to PGT in a.

Engrav et al. (2010) used the I-ScanTM System to obtain accurate measurements of the applied pressure during each of the five follow-up periods. A durometer specifically measured scar hardness and a chromameter specifically assessed scar color; these measurements were taken by a non-blinded research assistant. Scar thickness was measured using ultrasonography and clinical appearance was assessed by a blinded panel of ten burn providers. Following the 12 year study period, only 50% of the patient compliance data was available, but the mean garment wear time came out to 20.4 hours a day. The results found that the normal compression zone did have a greater mean pressure value but the mean pressure value fluctuated over time. When analyzing the effect of PGT on hardness and thickness, the wounds in the normal compression zone were found to be softer and thinner comparatively to the low compression zone. Pressure garment therapy was not found to have a statistically significant effect on scar color. When assessing the clinical appearance of the scaring at the end of the treatment period, the blinded panel could not consistently choose the correct compression zone. Thus, Engrav et al. (2010) suggests that continuous measurement of exact pressures in PGT is difficult, which is likely due to extraneous variables. Moreover, the researchers found PGT to have the most clinical benefits for patients with moderate to severe scarring, even when controlling for confounding variables.

In 2016, Pillay, Visagie, and Mij used a qualitative, phenomenological design to evaluate 179 total participants’ experiences with PGT for post-burn scar management. The participants were non-randomly selected from the Occupational Therapy (OT) department at a specialized burn unit in Cape Town South Africa. Participants were required to be at least 17 years of age, to have no cognitive impairments, and to reside within the Western Cape Metro health district. The primary author and OT selected these participants as she saw fit in order to obtain a relatively heterogeneous sample. During PGT implementation, a secondary OT conducted individual interviews with participants. Data saturation was reached by the eighth interview, at which point the primary OT conducted data analysis using her clinical expertise, relevant literature, and the Health Action Process Approach (HAPA) Model. The HAPA model was used primarily to understand patient non-adherence through changes in health behavior, specifically changes occurring in relation to both motivation and volition. Although patient non-adherence has been considered a barrier to the efficacy of PGT, this study failed to demonstrate poor patient adherence to PGT. The results found that only two out of the eight analyzed participants had poor adherence, whereas five participants had good overall adherence and one participant had average adherence.

Two tables were constructed to better understand the results of data analysis. Table 1 outlined demographic information, burn history, and overall patient adherence. According to Table 1, both burn area and burn severity influenced the course of PGT but neither seemed to impact each participant’s overall adherence. Table 2 defined specific facilitators and barriers in adherence to PGT under the HAPA model with regard to self-efficacy, risk awareness, outcome expectations, and resources. Within these four subcategories, facilitators were identified as: participants’ inner strength, awareness of outcomes, compliance with treatment, beliefs in improvement, perceived support from family and service providers, and ease of accessing PGT. Barriers in adherence to PGT were identified as: participants’ emotional turmoil, knowledge that PGT is not a cure, rigorous maintenance and effort, lack of emotional counseling, related physical symptoms, aesthetics of the garments themselves, and challenges to accessing PGT. Regardless of barriers or facilitators, however, the primary motivator to complete PGT was participants’ expectation of improved scar appearance following intervention. 

Various limitations were identified within the eight reviewed articles. For example, in Pillay et al. (2016) participants were non-randomly selected, raters were not blinded, no standardized assessments were used, and data was saturated by the eighth participant interview out of a total of 179 participants. In addition, Pillay et al. (2016) failed to reject the null hypothesis which proposed that poor patient adherence is a significant barrier to the efficacy of PGT. In the study by Li-Tsang et al. (2010), subjects commuted from rural areas, which made it difficult to attend follow-up assessments.    

Based on the above literature, the authors of this review came to the following conclusions: PGT is lacking in literature, expensive, difficult to monitor and evaluate, and impeded by extraneous variables. Although PGT has been shown to reduce scar height, thickness, and erythema, it has not been shown to increase maturation rate of hypertrophic scarring, improve scar pigmentation, or consistently work as a stand-alone treatment. When compared to silicone gel sheeting, self-drying silicone spray, physiotherapy and exercise, and treatments without PGT, PGT was not found to be consistently more or less effective.  This is the likely because there are no mechanisms available for taking true measurements of pressure while a garment is being worn. Van den Kerckhove et al. (2005) proposed that there are no reliable and accessible devices to measure pressure being applied to the scars under the garments in a clinical setting. Similarly, when patients are instructed to follow PGT protocol in a non-clinical setting, appropriate pressure grades and required hours of compression are more difficult to ensure. Patient compliance must also be considered in any setting where PGT is implemented, as any deterrence from PGT protocol can affect its effectiveness. Other variables that were not consistently accounted for included: blinding of patients, blinding of assessors, and the presence or absence of control groups. The inconsistency among reviewed articles implies a need for further research involving randomized controlled trials. Thus, the authors of this review conclude PGT remains a controversial treatment modality for post-burn scar management that requires further research to determine its efficacy.

References

• Atiyeh, B. S., El Khatib, A. M., & Dibo, S. A. (2013). Pressure garment therapy (PGT) of burn scars: Evidence-based efficacy. Annals of Burns and Fire Disasters, 26(4), 205-212. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3978593/
• Chang, P., Laubenthal, K. N., Lewis, R. W. II, Rosenquist, M. D., Lindley-Smith, P., & Kealey, G. P. (1995). Prospective, randomized study of the efficacy of pressure garment therapy in patients with burns. Journal of Burn Care & Rehabilitation, 16(5), 473–475. Retrieved from https://academic.oup.com/jbcr
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• Li, P., Li-Tsang, C. W. P., Deng, X., Wang, X., Wang, H., Zhang, Y., … He, C. (2018).The recovery of post-burn hypertrophic scar in a monitored pressure therapy intervention programme and the timing of intervention. Burns, 44(6),1451-1467. doi:10.1016/j.burns.2018.01.008
• Li-Tsang, C., Zheng, Y., & Lau, J. (2010). A randomized clinical trial to study the effect of silicone gel dressing and pressure therapy on posttraumatic hypertrophic scars. Journal of Burn Care & Research, 31(3), 448-457. Retrieved from https://ameriburn.org/research/journal/
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