Evaluation of BepanGel Hydrogel Efficacy and Tolerability Using an Abrasive Wound Model in a Within-Person, Single-Center, Randomized, Investigator-Blind Clinical Investigation

Autor: Lei Zhang, Raffaella de Salvo, Sonja Trapp, Walter Wigger-Alberti, Ragna Williams, Lucie Delcour, Bart Rossel, Maarten T. Huisman
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Zdroj: Dermatology and Therapy, Vol 10, Iss 5, Pp 1075-1088 (2020)
Druh dokumentu: article
ISSN: 2193-8210
2190-9172
DOI: 10.1007/s13555-020-00432-5
Popis: Abstract Introduction Over the last few years, it has been demonstrated that a moist environment enhances the healing process and reduces scar formation of wounds. Such moist conditions can be created and maintained using hydrogels. The aim of this study was to evaluate wound healing, cooling efficacy, local tolerability, and cosmetic appearance of abrasive wounds treated with BepanGel wound care hydrogel. Methods This study was designed as a within-person, single-center, randomized, investigator-blind clinical investigation comparing a hydrogel-treated test field with an untreated test field in an abrasive wound model. In 33 subjects, two small superficial wounds were induced on the non-dominant forearms. Wounds were treated with BepanGel and covered with a standard semi-occlusive wound plaster or covered with a plaster alone for 11 consecutive days. Wound healing efficacy, cooling effect, and tolerability of the treatment were assessed over 12 investigational days. During follow-up at day 31, the cosmetic appearance of the wounds was evaluated. Results On day 12, the test field treated with BepanGel was completely healed in nearly all subjects (97.0%) in contrast with the test field treated with a plaster alone (18.2%, AUCdays 2–12 p
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