Department for Oral and Maxillofacial Surgery/Plastic Surgery (Head: Prof. Dr. Dr. Hans-Robert Metelmann), Greifswald University, Ferdinand-Sauerbruch-Strasse BH1, D-17475 Greifswald, Germany.
J Craniomaxillofac Surg. 2012 Jul;40(5):e150-4. doi: 10.1016/j.jcms.2011.07.020. Epub 2011 Aug 26.
Intention of the study (EudraCT No 2009-017418-56) is a proof of aesthetic benefit of triterpene treatment in superficial wounds. In an open, prospective, controlled, randomized, blindly evaluated multicentre phase II clinical trial a triterpene ointment (OG-S10) is compared intra individually with a state-of-the-art moist wound healing dressing (Mepilex(®)) in split thickness skin graft donor sites. The graft wound areas at the upper leg were divided into two equal halves, one proximal and one distal site. Decided by randomization the one site was treated with triterpene and the other in comparison with moist dressing. Triterpene treatment went on for 14 days as covering the wound at every change of wound dressing with the ointment (100 mg/cm(2)). The comparative treatment went on as covering the site by this dressing alone. The outcome of these different treatments was evaluated by two blindly observing distant experts on the basis of photographs of the wound healing progress. Photographs were taken day 14, 3 month and 1 year after treatment. The only criterion for evaluation of the two sites was similarity of the wound area to the surrounding skin in terms of colour and texture: which of the two sites, the proximal or the distal, was aesthetically superior in normal skin appearance after 14 days at the end of treatment, after 3 month of follow up and 1 year after treatment? The descriptive comparison is demonstrating quite a remarkable advantage of the ointment versus the moist wound dressing in promoting wound healing: even having in mind the small number of 24 patients within the protocol, the superiority of aesthetic benefit by triterpene treatment after 14 days (22 out of 24 patients), after 3 month (15 out of 19 patients) and after 1 year (8 out of 10 patients) is obvious.
研究目的(EudraCT 编号 2009-017418-56)旨在证明三萜类化合物治疗浅部伤口的美学益处。在一项开放、前瞻性、对照、随机、盲法评估的多中心 II 期临床试验中,三萜类化合物软膏(OG-S10)与最先进的湿性伤口愈合敷料(Mepilex(®))在供皮区进行个体间比较。大腿上部的移植创面区域被分为两个相等的部分,一个是近端,一个是远端。通过随机分组,其中一个部位用三萜类化合物治疗,另一个部位用湿性敷料治疗。三萜类化合物治疗持续 14 天,每次更换敷料时,将软膏(100mg/cm(2))覆盖在伤口上。对照治疗仅用这种敷料覆盖创面。两名远距离观察的专家根据伤口愈合进展的照片对这些不同治疗的结果进行评估。照片在治疗后 14 天、3 个月和 1 年拍摄。评估这两个部位的唯一标准是根据颜色和质地,伤口区域与周围皮肤的相似程度:在治疗结束后 14 天、3 个月随访和 1 年后,哪一个部位,即近端还是远端,在正常皮肤外观上具有更好的美学优势?描述性比较显示,软膏在促进伤口愈合方面明显优于湿性伤口敷料:即使考虑到方案中只有 24 名患者,在 14 天(24 名患者中有 22 名)、3 个月(19 名患者中有 15 名)和 1 年后(10 名患者中有 8 名),三萜类化合物治疗的美学益处优势明显。