Li Xiaohui, Wu Honglin, Yang Hao, Wang Peng, Cao Xiaoling, Wang Peng, Chen Yongfei, Zhou Yuxi, Li Shuting, Hu Zhicheng, Zhu Jiayuan
Department of Burn and Wound Repair Surgery, The First Affiliated Hospital of Sun Yat-sen University, 58 Zhongshan Road II, Guangzhou, 510080, China.
Department of Plastic Surgery, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510080, China.
Stem Cell Res Ther. 2025 Jun 3;16(1):284. doi: 10.1186/s13287-025-04425-z.
Delayed or nonhealing wounds following surgery present a significant clinical challenge. Autologous epidermal cell regeneration technology has shown promise in enhancing wound healing. This study aimed to evaluate its efficacy in treating postoperative nonhealing wounds.
This randomized, controlled trial involved 151 patients with nonhealing postoperative wounds, randomly assigned to two groups: the experimental group ( = 75) received standard treatments combined with autologous epidermal cell regeneration technology, and the control group ( = 76) received standard treatments alone. The primary endpoint was wound healing at 3 weeks. Key secondary endpoints included time to complete healing and recurrence rate. Statistical tests were performed to determine the significance of differences between groups. The study was registered with UMIN-CTR (UMIN000056733).
In the intention-to-treat population, significantly more patients in the experimental group achieved the primary endpoint at week 3 (66 of 75 [88.0%] vs. 51 of 76 [67.1%]; difference 20.9%, 97.5% CI: 0.0802, 0.3377; = 0.004). Similar results were observed in the modified intention-to-treat population (62 of 71 [87.3%] vs. 47 of 73 [64.4.1%]; difference 22.9%, 97.5% CI: 0.0950, 0.3638; = 0.003). These results were confirmed in the per-protocol population (61 of 68 [89.7%] vs. 47 of 69 [68.1%]; difference 21.6%, 97.5% CI: 0.0843, 0.3475, = 0.004). In the safety analysis, 24.7% of the experimental group vs. 60.3% of the control group experienced treatment-emergent adverse events. The most common treatment-emergent adverse events were wound exudate and dehiscence, with no deaths or carcinogenicity reported.
Autologous epidermal cell regeneration technology is an effective and safe treatment for postoperative nonhealing wounds.
手术后伤口延迟愈合或不愈合是一项重大的临床挑战。自体表皮细胞再生技术在促进伤口愈合方面已显示出前景。本研究旨在评估其治疗术后不愈合伤口的疗效。
这项随机对照试验纳入了151例术后伤口不愈合的患者，随机分为两组：实验组（n = 75）接受标准治疗联合自体表皮细胞再生技术，对照组（n = 76）仅接受标准治疗。主要终点是3周时伤口愈合情况。关键次要终点包括完全愈合时间和复发率。进行统计检验以确定组间差异的显著性。该研究已在UMIN-CTR注册（UMIN000056733）。
在意向性分析人群中，实验组在第3周达到主要终点的患者明显更多（75例中的66例[88.0%] vs. 76例中的51例[67.1%]；差异20.9%，97.5%CI：0.0802，0.3377；P = 0.004）。在改良意向性分析人群中观察到类似结果（71例中的62例[87.3%] vs. 73例中的47例[64.4%]；差异22.9%，97.5%CI：0.0950，0.3638；P = 0.003）。这些结果在符合方案人群中得到证实（68例中的61例[89.7%] vs. 69例中的47例[68.1%]；差异21.6%，97.5%CI：0.0843，0.3475，P = 0.004）。在安全性分析中，实验组有24.7%的患者出现治疗中出现的不良事件，而对照组为60.3%。最常见的治疗中出现的不良事件是伤口渗出和裂开，未报告死亡或致癌情况。
自体表皮细胞再生技术是治疗术后不愈合伤口的一种有效且安全的方法。
