非侵袭性皮肤牵张闭合器在糖尿病足创面修复中的应用

Application of noninvasive skin-stretching device in wound healing of diabetic foot

目的 探讨非侵袭性皮肤牵张闭合器在糖尿病足坏疽行截趾术或清创术后创面修复过程中的应用价值.方法 自2017年5月至2018年3月共纳入51例Wanger 4级糖尿病足坏疽并行截趾术或清创术的患者,采取1:2配对前瞻性队列研究方法,分为治疗组17例和对照组34例[年龄(54.9±10.8)岁比(59.2±11.3)岁,足病病程1.0(1.0,4.1)个月比1.5(1.0,2.0)个月].两组均给予基础治疗和负压封闭引流治疗,待新鲜肉芽组织覆盖暴露骨质残端、创周无红肿热痛、创面内无脓性分泌物时,治疗组应用粘贴式非侵袭性皮肤牵张闭合器,对照组应用常规换药.观察时间为术后第1天至创面愈合或术后3个月,比较两组创面愈合率,同时利用Kaplan-Meier生存分析比较两组随时间变化的愈合率.结果 治疗组3个月创面愈合率高于对照组(94.1%比58.8%,χ^2=5.206,P<0.05);治疗组愈合时间短于对照组[42(41,59)d比78(50,90)d,Z=3.30,P<0.01].以最后一次负压封闭引流结束为时间起始点,两组Kaplan-Meier时间愈合曲线比较,治疗组愈合时间短于对照组,差异有统计学意义[13(8,14)d比42(26,42)d,Z=4.845,P<0.01].结论 糖尿病足坏疽患者术后在创面修复期应用非侵袭性皮肤牵张闭合器可以缩短创面愈合时间,提高创面愈合率.

Objective To evaluate the clinical value of noninvasive skin-stretching device in the healing of diabetic foot after toe amputation or debridement. Methods A total of 51 diabetic patients with diabetic foot gangrene at Wagner stage 4 after toe amputation or debridement were recruited in the study from May 2017 to March 2018 by using a prospective cohort design. The patients were assigned into trial group (n=17) and control group (n=34) and matched by 1:2 ratio [age:(54.9 ± 10.8) yrs vs (59.2 ± 11.3) yrs, duration of diabetic foot: 1.0(1.0, 4.1) months vs 1.5(1.0, 2.0) months]. All patients underwent basic treatment and vacuum sealing drainage therapy until exposing bones were covered by fresh granulation tissues and wound inflammation disappeared. The wounds of control group were received regular dressing change, and adhesive noninvasive skin-stretching devices were applied to the wounds of trial group. The wounds were observed from the 1st day to the day of wound healing or 3 months after surgery. Healing rates were compared, and Kaplan-Meier survival analysis was used for comparing cumulative wound healing rate over time between two groups. Results The healing rate of trial group was significantly higher than that of control group (94.1% vs 58.8%, χ^2=5.206, P<0.05). The differences of Kaplan-Meier healing time curve between two groups were statistically significant (P<0.01). Median of healing time in trial group was significantly shorter than that in control group [42 (41, 59) d vs 78 (50, 90) d, Z=3.30, P<0.01]. Taking the end of the last vacuum sealing drainage therapy as the starting point of time, the differences of Kaplan-Meier healing time curve between two groups were statistically significant (P<0.01), and the median of healing time in trial group was significantly shorter than that in control group [13 (8, 14) d vs 42 (26, 42) d,Z=4.845,P<0.01]. Conclusion The application of noninvasive skin-stretching device in diabetic foot gangrene in the&nbsp;repairation stage after surgery can reduce wound healing time and increase wound healing rate.