Within-Patient, Evaluator-Blinded, Randomized Controlled Clinical Trial to Assess the Efficacy of Gel Sheets in the Treatment of Hypertrophic Scar in Adult Burn Survivors.

Gel sheets have been used to treat hypertrophic scars (HSc) since the 1980s, though evidence for their efficacy-especially for burn-related HSc-is limited. This study conducted a randomized, evaluator-blinded trial to assess gel sheets on established burn HSc compared to intra-individual patient-matched control scars receiving usual care. Thirty-six adult burn survivors with 2 similar scars (based on ultrasound thickness > 2.034 mm and erythema index > 300) were enrolled. One scar per person was randomly assigned to receive gel sheets plus usual care, while the other received usual care only, over a 3-month period. Objective measures (thickness, elasticity, erythema, transepidermal water loss [TEWL], and melanin) were taken at baseline, monthly, and 1-month posttreatment. Itch and pain were self-reported, and adherence tracked monthly. An analysis of covariance (ANCOVA) after 3 months of treatment, and at 1-month posttreatment follow-up, controlling for pretreatment values, showed no significant difference between groups for thickness, elasticity, erythema, TEWL, melanin or itch intensity. However, ANCOVA revealed a significant increase in elasticity in the treated scars when only participants who wore the gel sheet over 16 h a day were analyzed. Comparisons of pretreatment to 3 months of all participants, using paired t-tests, showed a significant decrease in thickness and TEWL, and an increase in elasticity in both groups, but no significant change in erythema or melanin of either site. In conclusion, scar thickness, elasticity, and TEWL improved over time in both groups, but there was no significant between-group difference. However, gel sheets may enhance elasticity if worn over 16 h daily.