Betulin wound gel accelerated healing of superficial partial thickness burns: Results of a randomized, intra‐individually controlled, phase III trial with 12‐months follow‐up

Objective: Acceleration of wound healing promises advantages for patients and caregivers in reducing the burden of disease, avoiding complications such as wound infections, and improving the long-term outcome. However, medicines that can accelerate wound healing are lacking. The objective of this open, blindly evaluated, randomized, multicenter phase III study was to compare intra‐individually the efficacy and tolerability of Oleogel‐S10 with fatty gauze dressing versus Octenilin^® wound gel with fatty gauze dressing in accelerating the healing of superficial partial thickness burn wounds. Methods: Acute superficial partial thickness burn wounds in adults caused by fire, heat burn or scalding were divided into 2 halves and randomly assigned to treatment with Oleogel‐S10 or Octenilin^® wound gel. Photos for observer‐blinded analysis of wound healing were taken at each wound dressing change. Percentages of reepithelialization were assessed at defined intervals. Efficacy and tolerability were evaluated based on a 5‐point Likert scale. Results: Of 61 patients that were enrolled, 57 received the allocated intervention and 48 completed treatment. The percentage of patients with earlier wound healing was significantly higher for Oleogel‐S10 (85.7%, n = 30) compared to Octenilin^® wound gel (14.3%, n = 5, p < 0.0001). The mean intra‐individual difference in time to wound closure was −1.0 day in favour of Oleogel‐S10 (−1.4, −0.6; 95% CI, p < 0.0001). Most investigators (87.0%) and patients (84.8%) evaluated the efficacy of Oleogel‐S10 to be ‘better’ or ‘much better’ than that of Octenilin^® wound gel. Long-term outcome 3 months and 12 months post injury was improved in some patients. Conclusions: Oleogel‐S10 (Episalvan) significantly accelerated the healing of superficial partial thickness burn wounds. It was safe and well tolerated.