Barret Juan P, Podmelle Fred, Lipový Břetislav, Rennekampff Hans-Oliver, Schumann Hauke, Schwieger-Briel Agnes, Zahn Tobias R, Metelmann Hans-Robert
Department of Plastic Surgery and Burns, University Hospital Vall d'Hebron, Passeig de la Vall d'Hebron 119-129, 08035 Barcelona, Spain.
Department of Oral and Maxillofacial Surgery/Plastic Surgery, University Medicine Greifswald, Ferdinand-Sauerbruch-Str. DZ7, 17475 Greifswald, Germany.
Burns. 2017 Sep;43(6):1284-1294. doi: 10.1016/j.burns.2017.03.005. Epub 2017 Apr 8.
The clinical significance of timely re-epithelialization is obvious in burn care, since delayed wound closure is enhancing the risk of wound site infection and extensive scarring. Topical treatments that accelerate wound healing are urgently needed to reduce these sequelae. Evidence from preliminary studies suggests that betulin can accelerate the healing of different types of wounds, including second degree burns and split-thickness skin graft wounds. The goal of this combined study program consisting of two randomized phase III clinical trials in parallel is to evaluate whether a topical betulin gel (TBG) is accelerating re-epithelialization of split-thickness skin graft (STSG) donor site wounds compared to standard of care. Two parallel blindly evaluated, randomised, controlled, multicentre phase III clinical trials were performed in adults undergoing STSG surgery (EudraCT nos. 2012-003390-26 and 2012-000777-23). Donor site wounds were split into two equal halves and randomized 1:1 to standard of care (a non-adhesive moist wound dressing) or standard of care plus TBG consisting of 10% birch bark extract and 90% sunflower oil (Episalvan, Birken AG, Niefern-Oeschelbronn, Germany). The primary efficacy assessment was the intra-individual difference in time to wound closure assessed from digital photographs by three blinded experts. A total of 219 patients were included and treated in the two trials. Wounds closed faster with TBG than without it (15.3 vs. 16.5 days; mean intra-individual difference=-1.1 days [95% CI, -1.5 to -0.7]; p<0.0001). This agreed with unblinded direct clinical assessment (difference=-2.1 days [95% CI, -2.7 to -1.5]; p<0.0001). Adverse events possibly related to treatment were mild or moderate and mostly at the application site. TBG accelerates re-epithelialization of partial thickness wounds compared to the current standard of care, providing a well-tolerated contribution to burn care in practice.
及时重新上皮化在烧伤护理中的临床意义显而易见，因为伤口延迟愈合会增加伤口部位感染和广泛瘢痕形成的风险。迫切需要能加速伤口愈合的局部治疗方法来减少这些后遗症。初步研究证据表明，桦木醇可加速不同类型伤口的愈合，包括二度烧伤和中厚皮片移植伤口。这个由两项平行的随机III期临床试验组成的联合研究项目的目标是，评估与标准护理相比，局部用桦木醇凝胶（TBG）是否能加速中厚皮片移植（STSG）供皮区伤口的重新上皮化。对接受STSG手术的成年人进行了两项平行的、双盲评估的随机对照多中心III期临床试验（欧盟临床试验注册号：2012 - 003390 - 26和2012 - 000777 - 23）。供皮区伤口被分成两半，随机分为1:1接受标准护理（一种非粘性湿性伤口敷料）或标准护理加TBG，TBG由10%桦树皮提取物和90%向日葵油组成（Episalvan，Birken AG，德国尼费恩 - 厄舍尔布伦）。主要疗效评估是由三位盲法专家根据数码照片评估伤口闭合时间的个体内差异。两项试验共纳入并治疗了219例患者。使用TBG的伤口比未使用的愈合更快（15.3天对16.5天；个体内平均差异=-1.1天[95%CI，-1.5至-0.7]；p<0.0001）。这与非盲法直接临床评估结果一致（差异=-2.1天[95%CI，-2.7至-1.5]；p<0.0001）。可能与治疗相关的不良事件为轻度或中度，大多发生在用药部位。与当前标准护理相比，TBG可加速部分厚度伤口的重新上皮化，在实际烧伤护理中提供了耐受性良好的作用。
