Vascular Center, Malmö-Lund, Skåne University Hospital, Malmö, Sweden.
Department of Care Science, Malmö University, Malmö, Sweden; The Swedish Institute of Health Sciences, Lund University, Lund, Sweden.
J Vasc Surg. 2014 Jan;59(1):145-51. doi: 10.1016/j.jvs.2013.06.073. Epub 2013 Sep 20.
Vacuum-assisted wound closure (VAC) therapy may heal wounds faster than conventional dressings after surgical debridement of perivascular groin infections after vascular surgery.
Patients with deep infected wounds (Szilagyi grade III) were surgically revised and left open for secondary healing, then randomized to either VAC or alginate (Sorbalgon) therapy, between February 2007 and November 2011. To test the hypothesis, it was calculated that 42 patients needed to be included (90% power, 5% level of significance). It was decided to perform an interim analysis after inclusion of 20 patients.
Among 66 patients undergoing groin revision, 20 patients were included in this study. Patients were randomized to VAC (n = 10) or alginate (n = 10). The two groups were comparable in patient and wound characteristics. Time to full skin epithelialization was significantly shorter in the VAC group (median, 57 days) compared with the alginate group (median, 104 days; P = .026). The number of positive wound cultures of bacteria and C-reactive protein values decreased equally in both groups between surgical revision and day 21. One femur amputation was performed in each group as a consequence of the groin infection, one patient died during the in-hospital stay in the alginate group, and none died in the VAC group.
VAC achieves faster healing than alginate therapy after wound debridement for deep perivascular wound infections in the groin after vascular surgery. This finding does not allow further inclusion of patients from an ethical point of view, and this study was, therefore, stopped prematurely.
血管手术后,血管外科清创术治疗股周血管旁感染引起的深伤口(Szilagyi Ⅲ级)后,负压辅助伤口闭合(VAC)治疗可能比常规敷料更快地促进伤口愈合。
深感染伤口(Szilagyi Ⅲ级)患者接受手术修正,并留作二期愈合,然后在 2007 年 2 月至 2011 年 11 月之间随机分为 VAC 或藻酸(Sorbalgon)治疗组。为验证假设,计算出需要纳入 42 例患者(90%效能,5%水平)。决定在纳入 20 例患者后进行中期分析。
在 66 例腹股沟翻修患者中,20 例患者纳入本研究。患者随机分为 VAC 组(n = 10)或藻酸盐组(n = 10)。两组患者的患者和伤口特征具有可比性。VAC 组完全上皮化的时间明显短于藻酸盐组(中位数,57 天)(中位数,104 天;P =.026)。两组之间,在手术修正和第 21 天之间,细菌的阳性伤口培养物的数量和 C 反应蛋白值同样减少。由于腹股沟感染,每组各进行 1 例股骨截肢,藻酸盐组有 1 例患者在住院期间死亡,VAC 组无人死亡。
VAC 在血管手术后深血管旁股周感染清创后,与藻酸盐治疗相比,可更快地愈合伤口。这一发现从伦理角度来看不允许进一步纳入患者,因此本研究提前终止。