Hauser J, Rossbach O, Vogt P M, Reimer K, Bosse B, Fleischer W, Steinau H U
Universitätsklinik für Plastische Chirurgie und Schwerbrandverletzte, BG-Kliniken Bergmannshell, Ruhr-Universität Bochum.
Zentralbl Chir. 2006 Aug;131(4):315-21. doi: 10.1055/s-2006-933479.
Moist wound treatment is a well recognized method for the treatment of aseptic acute and chronic wounds. While the moist environment is beneficial to the woundhealing process, it also increases the risk of bacterial superinfection. We here report on the results of a clinical phase-III-study in which we tested the effect of a new PVP-iodine liposomal hydrogel (Repithel) on split-thickness skin grafts. This formulation optimizes moist wound treatment by improving the cell proliferation rate while preventing wound infection.
The aim of this phase-III-study was to analyse the efficacy and tolerance of Repithel in patients receiving meshed skin grafts.
167 patients with transplantation wounds were either treated with lipid gauze alone (control group) or with lipid gauze and Repithel. In both groups the extent of neoepithelization, the frequency and severity of graft losses and the time until complete wound closure was achieved were determined. Analysis of the re-epithelization was achieved by photoplanimetry. Impedance measurements gave additional information on the regeneration of the epidermal barrier.
Wounds receiving Repithel showed a significantly faster neoepithelisation than wounds which were treated with lipid gauze alone. Treatment with Repithel significantly reduced both the number of graft losses and the size of area lost. The time until wounds were closed completely was significantly shorter in patients receiving Repithel than in controls. The positive effects of Repithel on wound healing were especially observed in smokers, patients with chronic wounds, burns or infected wounds.
Repithel supports healing of meshgraft transplants and reduces the risk of graft loss. Patients who heal poorly benefit particularly from the Repithel treatment.
湿性伤口治疗是一种公认的治疗无菌性急性和慢性伤口的方法。虽然潮湿环境有利于伤口愈合过程,但也增加了细菌二重感染的风险。我们在此报告一项临床III期研究的结果,该研究中我们测试了一种新型聚维酮碘脂质体水凝胶(Repithel)对中厚皮片移植的效果。这种制剂通过提高细胞增殖率同时预防伤口感染来优化湿性伤口治疗。
本III期研究的目的是分析Repithel在接受网状皮肤移植患者中的疗效和耐受性。
167例移植伤口患者,一部分仅用脂质纱布治疗(对照组),另一部分用脂质纱布和Repithel治疗。两组均测定新生上皮化程度、移植失败的频率和严重程度以及实现完全伤口闭合所需的时间。通过摄影测量法分析再上皮化情况。阻抗测量提供了有关表皮屏障再生的更多信息。
接受Repithel治疗的伤口新生上皮化明显快于仅用脂质纱布治疗的伤口。Repithel治疗显著减少了移植失败的数量和损失面积的大小。接受Repithel治疗的患者伤口完全闭合的时间明显短于对照组。Repithel对伤口愈合的积极作用尤其在吸烟者、慢性伤口患者、烧伤患者或感染伤口患者中观察到。
Repithel有助于网状移植皮片的愈合并降低移植失败的风险。愈合不良的患者尤其从Repithel治疗中获益。