Kiefer Jurij, Harati Kamran, Müller-Seubert Wibke, Fischer Sebastian, Ziegler Benjamin, Behr Björn, Gille Jochen, Kneser Ulrich, Lehnhardt Marcus, Daigeler Adrien, Dragu Adrian
Department of Hand, Plastic and Reconstructive Surgery, Burn Center, BG Trauma Center Ludwigshafen, Plastic and Hand Surgery, University of Heidelberg, Germany.
Department of Plastic Surgery, Burn Center, Sarcoma Center, BG University Hospital, Ruhr University, Bochum, Germany.
J Burn Care Res. 2018 Aug 17;39(5):685-693. doi: 10.1093/jbcr/iry019.
Despite overall advances in burn therapy, wound infection remains one of the leading causes of morbidity and mortality in patients with severe burn injuries. This prospective, multicenter, noncomparative clinical trial was conducted to assess the efficacy and safety of Prontosan® Wound Gel X (PWX), a gel containing polihexanide and betaine, for moistening and cleansing in deep tissue burn wounds requiring split-thickness skin grafting. Patients with deep partial or full thickness burn wounds requiring split-thickness skin grafting were treated with the gel to evaluate its tolerability and safety as well as graft take and the healing of the skin graft. Target wounds were assessed clinically and by using a photo-planimetric analyzing software for re-epithelialization. From 04/2012 to 05/2015, burn patients from three burn centers in Germany were screened for the study, of which 51 patients met the inclusion criteria. Predominantly deep partial thickness burn wounds were found (88.2 %). Except for one graft failure, all patients reached complete re-epithelialization after one (n = 14), two (n = 31), or three (n = 5) administrations of the gel. The median time to complete graft take was 7 days and was below the average healing time reported in comparable studies. No wound infection or erythema occurred. This is the first study to document the outcomes of deep partial and full thickness burns treated with PWX for moistening and cleansing. The gel was shown to be efficacious, safe, and well tolerated for use in burn wounds requiring split-thickness skin grafts.
尽管烧伤治疗取得了全面进展，但伤口感染仍是严重烧伤患者发病和死亡的主要原因之一。本前瞻性、多中心、非对照临床试验旨在评估含有聚己双胍和甜菜碱的Prontosan®伤口凝胶X（PWX）在需要进行中厚皮片移植的深部组织烧伤伤口的湿润和清洁方面的疗效和安全性。对需要进行中厚皮片移植的深Ⅱ度或全层烧伤伤口患者使用该凝胶进行治疗，以评估其耐受性、安全性以及植皮成活情况和皮肤移植的愈合情况。通过临床评估和使用照片平面测量分析软件对目标伤口的再上皮化情况进行评估。2012年4月至2015年5月，对德国三个烧伤中心的烧伤患者进行了该研究的筛查，其中51例患者符合纳入标准。主要发现为深Ⅱ度烧伤伤口（88.2%）。除1例植皮失败外，所有患者在使用1次（n = 14）、2次（n = 31）或3次（n = 5）凝胶后均实现了完全再上皮化。完成植皮成活的中位时间为7天，低于同类研究报告的平均愈合时间。未发生伤口感染或红斑。这是第一项记录使用PWX进行湿润和清洁治疗深Ⅱ度和全层烧伤结果的研究。结果表明，该凝胶在需要进行中厚皮片移植的烧伤伤口中使用有效、安全且耐受性良好。
