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

Quentin Frew; Hans-Oliver Rennekampff; Peter Dziewulski; Naiem Moiemen; BBW-11 Study Group; Tobias Zahn; Bernd Hartmann

doi:10.1016/j.burns.2018.10.019

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

Burns. 2019 Jun;45(4):876-890. doi: 10.1016/j.burns.2018.10.019. Epub 2018 Dec 14.

Authors

Quentin Frew¹, Hans-Oliver Rennekampff², Peter Dziewulski¹, Naiem Moiemen³; BBW-11 Study Group; Tobias Zahn⁴, Bernd Hartmann⁵

Affiliations

¹ St. Andrew's Centre for Plastic Surgery and Burns, Mid Essex Hospitals Trust, Broomfield Hospital, Chelmsford, UK.
² Department of Plastic, Aesthetic and Burn Surgery, Rhein-Maas Klinikum, Würselen, Germany.
³ Burns and Plastics, University Hospitals Birmingham NHS Foundation Trust Queen Elisabeth Hospital, Birmingham, UK.
⁴ Birken AG, Niefern-Öschelbronn, Germany.
⁵ Burn Center with Plastic Surgery, Unfallkrankenhaus Berlin, Germany. Electronic address: bernd.hartmann@ukb.de.

PMID: 30559054
DOI: 10.1016/j.burns.2018.10.019

Abstract

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.

Keywords: Betulin; Birch bark extract; Grade 2a burns; Partial thickness wounds; Randomized clinical trial; Superficial partial thickness burns.

Publication types

Clinical Trial, Phase III
Randomized Controlled Trial

MeSH terms

Administration, Cutaneous
Adolescent
Adult
Aged
Bandages
Burns / drug therapy*
Female
Gels
Humans
Male
Middle Aged
Organic Chemicals / therapeutic use
Re-Epithelialization
Time Factors
Treatment Outcome
Triterpenes / therapeutic use*
Wound Healing*
Young Adult

Substances

Gels
Organic Chemicals
Triterpenes
oleogels
betulin