Efficacy and safety of clostridial collagenase ointment in patients with non-burn acute skin wounds: a multicenter, randomised, parallel controlled clinical trial

In our multicenter, randomised, parallel controlled clinical trial, we found that the clostridial collagenase ointment (CCO), which contains a mixture of collagenases and non-specific proteases derived from the fermentation of Clostridium histolyticum, could significantly increase the epithelial coverage, shorten the healing time and improve long term scar outcomes compared with standard medical treatment in patients with non-burn acute skin wounds. Meanwhile, CCO demonstrated good tolerability and a safety profile similar to conventional medical treatment. This trial provides the first randomised evidence that CCO achieves dual benefits of faster healing and superior long-term scar outcomes in acute wounds, filling an important unmet need in current wound management.在本项多中心随机平行对照临床试验中，我们发现：由溶组织梭菌（Clostridium histolyticum）发酵制备的胶原酶与非特异性蛋白酶混合制剂——梭菌胶原酶软膏（CCO），相较于标准医疗方案，可显著提升非烧伤性急性皮肤创面患者的上皮覆盖率、缩短创面愈合时间，并改善远期瘢痕结局。同时，CCO具备良好的耐受性，其安全性特征与常规医疗方案相仿。本试验首次提供随机对照研究证据，证实CCO可实现创面快速愈合与优良远期瘢痕结局的双重获益，填补了当前创面管理领域一项重要的未被满足的临床需求。