Accelerated re-epithelialization of partial-thickness skin wounds by a topical betulin gel: Results of a randomized phase III clinical trials program

BARRET, J.P., F. PODMELLE, Břetislav LIPOVÝ, H.O. RENNEKAMPFF, H. SCHUMANN, A. SCHWIEGER-BRIEL, T.R. ZAHN and H.R. METELMANN. Accelerated re-epithelialization of partial-thickness skin wounds by a topical betulin gel: Results of a randomized phase III clinical trials program. Burns. OXFORD: ELSEVIER SCI LTD, 2017, vol. 43, No 6, p. 1284-1294. ISSN 0305-4179. Available from: https://dx.doi.org/10.1016/j.burns.2017.03.005.

Basic information

Original name

Accelerated re-epithelialization of partial-thickness skin wounds by a topical betulin gel: Results of a randomized phase III clinical trials program

Authors

BARRET, J.P., F. PODMELLE, Břetislav LIPOVÝ, H.O. RENNEKAMPFF, H. SCHUMANN, A. SCHWIEGER-BRIEL, T.R. ZAHN and H.R. METELMANN

Edition

Burns, OXFORD, ELSEVIER SCI LTD, 2017, 0305-4179

---

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30218 General and internal medicine

Country of publisher

United Kingdom of Great Britain and Northern Ireland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 2.134

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1016/j.burns.2017.03.005

UT WoS

000410623300019

Keywords in English

Wound healing; Topical betulin gel; Split thickness skin graft; Intra-individual comparison; Wound closure

Tags

EL OK

Tags

International impact, Reviewed

---

Abstract

V originále

The clinical significance of timely re-epithelialization is obvious in burn care, since delayedwound closure is enhancing the risk of wound site infection and extensive scarring. Topical treatments that accelerate wound healing are urgently needed to reduce these sequelae. Evidence from preliminary studies suggests that betulin can accelerate the healing of different types of wounds, including second degree burns and split-thickness skin graft wounds. The goal of this combined study program consisting of two randomized phase III clinical trials in parallel is to evaluate whether a topical betulin gel (TBG) is accelerating reepithelialization of split-thickness skin graft (STSG) donor site wounds compared to standard of care. Two parallel blindly evaluated, randomised, controlled, multicentre phase III clinical trialswere performed in adults undergoing STSG surgery (EudraCT nos. 2012-003390-26 and 2012-000777-23). Donor site wounds were split into two equal halves and randomized 1: 1 to standard of care (a non-adhesive moist wound dressing) or standard of care plus TBG consisting of 10% birch bark extract and 90% sunflower oil (Episalvan, Birken AG, Nieferm-Oeschelbronn, Germany). The primary efficacy assessment was the intra-individual difference in time to wound closure assessed from digital photographs by three blinded experts. A total of 219 patients were included and treated in the two trials. Wounds closed faster with TBG than without it (15.3 vs. 16.5 days; mean intra-individual difference=-1.1 days [95% CI, 1.5 to 0.7]; p<0.0001). This agreed with unblinded direct clinical assessment (difference=-2.1 days [95% CI, -2.7 to -1.5]; p<0.0001). Adverse events possibly related to treatment were mild or moderate and mostly at the application site. TBG accelerates re-epithelialization of partial thickness wounds compared to the current standard of care, providing a well-tolerated contribution to burn care in practice. (C) 2017 The Authors. Published by Elsevier Ltd.