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

Abstract 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 two 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; the other received usual care only, over a 3-month period. Objective measures (thickness, elasticity, erythema, transepidermal water loss (TEWL), melanin) were taken at baseline, monthly, and one-month post-treatment. Itch and pain were self-reported, and adherence tracked monthly. An analysis of covariance (ANCOVA) after 3-months of treatment, and at 1-month post-treatment follow up, controlling for pre-treatment 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 hours daily were analyzed. Comparisons of pre-treatment 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 hours daily.