NHMRC Centre of Research Excellence in Nursing (NCREN), Centre for Health Practice Innovation, Griffith Health Institute, Griffith University, Gold Coast Campus, QLD 4222, Australia.
Centre for Clinical Nursing, Royal Brisbane and Women's Hospital, Butterfield Street, Herston, QLD 4029, Australia.
Healthcare (Basel). 2014 Sep 30;2(4):417-28. doi: 10.3390/healthcare2040417.
Obese women undergoing caesarean section (CS) are at increased risk of surgical site infection (SSI). Negative Pressure Wound Therapy (NPWT) is growing in use as a prophylactic approach to prevent wound complications such as SSI, yet there is little evidence of its benefits. This pilot randomized controlled trial (RCT) assessed the effect of NPWT on SSI and other wound complications in obese women undergoing elective caesarean sections (CS) and also the feasibility of conducting a definitive trial. Ninety-two obese women undergoing elective CS were randomized in theatre via a central web based system using a parallel 1:1 process to two groups i.e., 46 women received the intervention (NPWT PICO™ dressing) and 46 women received standard care (Comfeel Plus(®) dressing). All women received the intended dressing following wound closure. The relative risk of SSI in the intervention group was 0.81 (95% CI 0.38-1.68); for the number of complications excluding SSI it was 0.98 (95% CI 0.34-2.79). A sample size of 784 (392 per group) would be required to find a statistically significant difference in SSI between the two groups with 90% power. These results demonstrate that a larger definitive trial is feasible and that careful planning and site selection is critical to the success of the overall study.
肥胖女性行剖宫产术（CS）时，发生手术部位感染（SSI）的风险增加。负压伤口疗法（NPWT）作为一种预防措施，越来越多地用于预防 SSI 等伤口并发症，但关于其益处的证据有限。本先导随机对照试验（RCT）评估了 NPWT 对肥胖女性行择期剖宫产术（CS）时 SSI 及其他伤口并发症的影响，同时评估了进行确定性试验的可行性。92 名肥胖女性在手术室中通过中央网络系统以平行 1:1 的方式随机分为两组，46 名女性接受干预（NPWT PICO™ 敷料），46 名女性接受标准护理（Comfeel Plus(®) 敷料）。所有女性在伤口闭合后均接受预期的敷料。干预组 SSI 的相对风险为 0.81（95%CI 0.38-1.68）；不包括 SSI 的并发症数量的相对风险为 0.98（95%CI 0.34-2.79）。需要 784 名（每组 392 名）参与者才能在两组之间发现 SSI 的统计学差异，具有 90%的效力。这些结果表明，更大规模的确定性试验是可行的，并且仔细的规划和站点选择对于整个研究的成功至关重要。
