Supplementary Material for: Accelerated Reepithelialization by Triterpenes: Proof of Concept in the Healing of Surgical Skin Lesions

The acceleration of wound healing is a major surgical concern. A triterpene extract from birch bark (Betulae cortex) experimentally enhances keratinocyte differentiation in vitro and accelerates wound healing ex vivo. We conducted an open, blind-evaluated, controlled, prospective, randomized (1:1) phase II clinical trial in patients requiring split-thickness skin graft transplantation at two university hospitals in Germany. Donor sites on the upper legs were covered with a moist silicone-coated dressing. Oleogel-S10 ointment containing 10% birch bark extract was randomly applied to the distal or proximal half of the wound, with the other half serving as an intraindividual control, for 14 days after the skin graft surgery. The primary efficacy variable was faster reepithelialization as determined from macrophotographs by independent, blinded experts. Twenty-four patients were randomized and completed the trial. After the 14-day test period, the planned interim analysis revealed a highly significant (p < 0.0001) superiority of Oleogel-S10 in the primary efficacy variable and the trial was terminated early due to ethical concerns. The treatment side was also better reepithelialized and more similar to normal skin after 3 months. In conclusion, Oleogel-S10 significantly accelerated reepithelialization at split-thickness skin graft donor sites. Treatment with Oleogel-S10 was safe and well tolerated. i 2014 S. Karger AG, Basel促进伤口愈合是外科领域的核心关切之一。桦树皮（Betulae cortex）来源的三萜提取物可在体外实验性增强角质形成细胞分化，并在离体模型中加速伤口愈合。我们在德国两所大学医院开展了一项开放、盲法评估、对照、前瞻性、1:1随机分组的II期临床试验，受试者为需接受刃厚皮片移植的患者。大腿上段的供皮区采用湿性硅酮涂层敷料覆盖。含10%桦树皮提取物的Oleogel-S10软膏被随机涂抹于创面的远端或近端半侧，另一侧作为个体内对照，于皮片移植术后连续给药14天。主要疗效变量为经盲法独立专家通过宏观摄影图像评估的上皮再生速度。共计24例患者完成随机入组并全程完成试验。在14天试验周期结束后，预设的中期分析显示Oleogel-S10在主要疗效变量上具有极显著优势（p < 0.0001），试验因伦理考量提前终止。术后3个月时，给药侧创面的上皮再生程度更佳，且形态更接近正常皮肤。综上，Oleogel-S10可显著加速刃厚皮片供皮区的上皮再生。该治疗方案安全性良好，耐受性佳。© 2014 S. Karger AG, 巴塞尔