1. Evaluation of BepanGel Hydrogel Efficacy and Tolerability Using an Abrasive Wound Model in a Within-Person, Single-Center, Randomized, Investigator-Blind Clinical Investigation
- Author
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Ragna Williams, Bart Rossel, Raffaella de Salvo, Lucie Delcour, Lei Zhang, Sonja Trapp, Maarten T Huisman, and W. Wigger-Alberti
- Subjects
medicine.medical_specialty ,Efficacy ,Dermatology ,Single Center ,Zoralan ,030207 dermatology & venereal diseases ,03 medical and health sciences ,Wound care ,Hydrocolloid ,0302 clinical medicine ,Clinical investigation ,medicine ,Adverse effect ,Cosmetic appearance ,Original Research ,BepanGel ,integumentary system ,business.industry ,Tolerability ,Abrasive wound model ,Surgery ,Hydrogel ,Plastic surgery ,RL1-803 ,030220 oncology & carcinogenesis ,Flamozil ,Oral and maxillofacial surgery ,Cooling ,Wound healing ,business - 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
- Published
- 2020
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