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

J 2017

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 et. al.

Základní údaje

Originální název

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

Autoři

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

Vydání

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

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30218 General and internal medicine

Stát vydavatele

Velká Británie a Severní Irsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 2.134

Organizační jednotka

Lékařská fakulta

DOI

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

UT WoS

000410623300019

Klíčová slova anglicky

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

Štítky

EL OK

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 16. 3. 2018 14:04, Soňa Böhmová

Anotace

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.

Citovat

BARRET, J.P., F. PODMELLE, Břetislav LIPOVÝ, H.O. RENNEKAMPFF, H. SCHUMANN, A. SCHWIEGER-BRIEL, T.R. ZAHN a 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, roč. 43, č. 6, s. 1284-1294. ISSN 0305-4179. Dostupné z: https://dx.doi.org/10.1016/j.burns.2017.03.005.

@article{1398336,
   author = {Barret, J.P. and Podmelle, F. and Lipový, Břetislav and Rennekampff, H.O. and Schumann, H. and SchwiegerandBriel, A. and Zahn, T.R. and Metelmann, H.R.},
   article_location = {OXFORD},
   article_number = {6},
   doi = {http://dx.doi.org/10.1016/j.burns.2017.03.005},
   keywords = {Wound healing; Topical betulin gel; Split thickness skin graft; Intra-individual comparison; Wound closure},
   language = {eng},
   issn = {0305-4179},
   journal = {Burns},
   title = {Accelerated re-epithelialization of partial-thickness skin wounds by a topical betulin gel: Results of a randomized phase III clinical trials program},
   url = {http://dx.doi.org/10.1016/j.burns.2017.03.005},
   volume = {43},
   year = {2017}
}

TY  - JOUR
ID  - 1398336
AU  - Barret, J.P. - Podmelle, F. - Lipový, Břetislav - Rennekampff, H.O. - Schumann, H. - Schwieger-Briel, A. - Zahn, T.R. - Metelmann, H.R.
PY  - 2017
TI  - Accelerated re-epithelialization of partial-thickness skin wounds by a topical betulin gel: Results of a randomized phase III clinical trials program
JF  - Burns
VL  - 43
IS  - 6
SP  - 1284-1294
EP  - 1284-1294
PB  - ELSEVIER SCI LTD
SN  - 03054179
KW  - Wound healing
KW  - Topical betulin gel
KW  - Split thickness skin graft
KW  - Intra-individual comparison
KW  - Wound closure
UR  - http://dx.doi.org/10.1016/j.burns.2017.03.005
L2  - http://dx.doi.org/10.1016/j.burns.2017.03.005
N2  - 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.
ER  -

BARRET, J.P., F. PODMELLE, Břetislav LIPOVÝ, H.O. RENNEKAMPFF, H. SCHUMANN, A. SCHWIEGER-BRIEL, T.R. ZAHN a 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. \textit{Burns}. OXFORD: ELSEVIER SCI LTD, 2017, roč.~43, č.~6, s.~1284-1294. ISSN~0305-4179. Dostupné z: https://dx.doi.org/10.1016/j.burns.2017.03.005.

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