James Sangma M D, Sureshkumar Sathasivam, Elamurugan Thirthar P, Debasis Naik, Vijayakumar Chellappa, Palanivel Chinnakali
Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.
Department of Preventive and Social Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.
Niger J Surg. 2019 Jan-Jun;25(1):14-20. doi: 10.4103/njs.NJS_14_18.
Vacuum-assisted closure (VAC) therapy has been shown to be beneficial in a variety of wounds. However, evidence of its benefit in diabetic foot ulcers (DFUs), especially with respect to Indian population, is sparse.
This randomized controlled trial included DFUs of Wagner's Grades 1 and 2. Patients were further stratified with respect to DFU size <10 cm and ≥10 cm. Patients with vascular disease, osteomyelitis, and bilateral DFUs were excluded from the study. The enrolled patients were randomized to receive VAC therapy or conventional dressing. The time to wound healing, granulation tissue formation, and complications such as pain, infection, and bleeding were compared between the two groups.
A total of sixty patients were randomized, of which 27 in each group were analyzed. The mean time to healing in days was significantly less in VAC group (22.52 vs. 3.85; < 0.0001). Mean time to achieve 75%-100% granulation tissue cover was significantly less in VAC group (23.33 vs. 32.15; < 0.0001). Rate of granulation tissue formation was also found to be significantly better in VAC group (2.91 cm/day vs. 2.16 cm/day; = 0.0306). There was no difference between the two groups with respect to wound infection and bleeding which are commonly attributed to VAC therapy. VAC therapy group had significantly lesser pain at week 3 (Visual Analog Scale score 3 vs. 4; = 0.004).
VAC therapy significantly decreases the time to complete wound healing, hastens granulation tissue formation, and reduces the ulcer area compared to conventional dressing. The study did not find any significant increase in the bleeding and infection in the VAC therapy group.
负压封闭引流(VAC)疗法已被证明对多种伤口有益。然而,其在糖尿病足溃疡(DFU)中的益处证据,尤其是针对印度人群的证据却很稀少。
这项随机对照试验纳入了瓦格纳分级为1级和2级的DFU。患者还根据DFU大小<10 cm和≥10 cm进行了进一步分层。患有血管疾病、骨髓炎和双侧DFU的患者被排除在研究之外。纳入的患者被随机分配接受VAC疗法或传统敷料。比较了两组之间伤口愈合时间、肉芽组织形成情况以及疼痛、感染和出血等并发症。
共有60名患者被随机分组,每组各有27名患者接受分析。VAC组的平均愈合天数显著更少(22.52天对32.85天;P<0.0001)。VAC组达到75%-100%肉芽组织覆盖的平均时间显著更少(23.33天对32.15天;P<0.0001)。还发现VAC组的肉芽组织形成速率明显更好(2.91 cm/天对2.16 cm/天;P = 0.0306)。两组在通常归因于VAC疗法的伤口感染和出血方面没有差异。VAC疗法组在第3周时疼痛明显减轻(视觉模拟评分3分对4分;P = 0.004)。
与传统敷料相比,VAC疗法显著缩短了伤口完全愈合的时间,加速了肉芽组织形成,并减小了溃疡面积。该研究未发现VAC疗法组的出血和感染有任何显著增加。