Zhang Lei, de Salvo Raffaella, Trapp Sonja, Wigger-Alberti Walter, Williams Ragna, Delcour Lucie, Rossel Bart, Huisman Maarten T
Bayer Consumer Care AG, Peter Merian-Strasse 84, 4002, Basel, Switzerland.
Bioskin GmbH, Messberg 4, 20095, Hamburg, Germany.
Dermatol Ther (Heidelb). 2020 Oct;10(5):1075-1088. doi: 10.1007/s13555-020-00432-5. Epub 2020 Aug 2.
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.
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.
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%, AUC p < 0.0001) as assessed by a blinded investigator. Two-thirds of the unblinded subjects indicated an immediate cooling effect of the hydrogel (p = 0.0555). At the end of the investigation, the cosmetic appearance of the BepanGel-treated test fields scored superior to the fields treated with a plaster alone as evaluated by a blinded investigator (p = 0.0005) and the unblinded subjects (p = 0.0078). The hydrogel was generally well tolerated and no signs of infection or adverse events (AEs) related to the treatment were observed.
This evaluation shows that treatment of superficial cutaneous wounds with BepanGel results in improved wound healing as demonstrated by faster wound closure and a considerably better cosmetic appearance, while providing immediate cooling.
EUDAMED-No.: CIV-19-09-029744.
在过去几年中，已证实潮湿环境可促进伤口愈合过程并减少伤口疤痕形成。使用水凝胶可创造并维持这种潮湿条件。本研究的目的是评估用贝潘凝胶伤口护理水凝胶治疗的擦伤伤口的愈合情况、降温效果、局部耐受性和外观。
本研究设计为一项自身对照、单中心、随机、研究者盲法的临床研究，在擦伤伤口模型中比较水凝胶治疗的试验区域和未治疗的试验区域。在33名受试者的非优势前臂上造成两个小的浅表伤口。伤口用贝潘凝胶治疗，并连续11天用标准半封闭伤口敷料覆盖或仅用敷料覆盖。在12个研究日期间评估伤口愈合效果、降温效果和治疗耐受性。在第31天随访时，评估伤口的外观。
在第12天，经盲法研究者评估，与仅用敷料治疗的试验区域相比（18.2%，AUC p<0.0001），用贝潘凝胶治疗的试验区域在几乎所有受试者（97.0%）中完全愈合。三分之二未盲法的受试者表示水凝胶有即时降温效果（p=0.0555）。在研究结束时，经盲法研究者评估（p=0.0005）和未盲法的受试者评估（p=0.0078），用贝潘凝胶治疗的试验区域的外观得分优于仅用敷料治疗的区域。水凝胶总体耐受性良好，未观察到与治疗相关的感染迹象或不良事件（AE）。
该评估表明，用贝潘凝胶治疗浅表皮肤伤口可改善伤口愈合，表现为伤口闭合更快且外观明显更好，同时提供即时降温。
EUDAMED编号：CIV-19-09-029744。
