Department of Surgery, Middlemore Hospital, Auckland, New Zealand.
Ann Surg. 2013 Jul;258(1):59-65. doi: 10.1097/SLA.0b013e3182895b8c.
To determine whether gentamicin-impregnated collagen sponges (gentamicin-collagen implants) decrease the incidence of surgical site infection (SSI).
SSIs cause substantial morbidity and increase the costs of healthcare. Antibiotic prophylaxis is a cornerstone of SSI reduction. Prophylactic local delivery of antibiotics with novel biodegradable drug carrier systems, such as the gentamicin-collagen implant, is a potential avenue for SSI reduction. Gentamicin-collagen implants have been previously assessed in multiple randomized controlled trials (RCTs) with conflicting results. Therefore, a systematic review and meta-analysis of all relevant RCTs was conducted to determine whether gentamicin-collagen implants reduce SSI.
Major medical databases and trial registers were searched for published and unpublished RCTs. The endpoint of interest was the incidence of SSI. A random effects model was used and pooled estimates were reported as odds ratios (ORs), with the corresponding 95% confidence interval (CI). A subset analysis by incision type was planned a priori.
Fifteen RCTs encompassing a total of 6979 patients were included in the final analysis. The included studies were of moderate to high quality. Gentamicin-collagen implants significantly reduced SSI [OR = 0.51; 95% CI: 0.33-0.77; P = 0.001; number needed to treat (NNT) = 21; I = 75%]. These results were seen in subset analysis of clean (OR = 0.53; 95% CI: 0.33-0.87; P = 0.01; NNT = 30) and clean-contaminated surgery (OR = 0.43; 95% CI: 0.20-0.93; P = 0.03; NNT = 9) specifically.
Gentamicin-collagen implants decrease the rate of SSI.
确定庆大霉素胶原蛋白海绵（庆大霉素-胶原蛋白植入物）是否能降低手术部位感染（SSI）的发生率。
SSI 会导致严重的发病率，并增加医疗保健的成本。抗生素预防是降低 SSI 的基石。使用新型可生物降解药物载体系统（如庆大霉素-胶原蛋白植入物）局部递送抗生素是降低 SSI 的一种潜在途径。庆大霉素-胶原蛋白植入物已在多项随机对照试验（RCT）中进行了评估，但结果相互矛盾。因此，进行了一项系统评价和荟萃分析，以确定庆大霉素-胶原蛋白植入物是否能降低 SSI。
检索了主要医学数据库和试验登记处，以寻找已发表和未发表的 RCT。关注的终点是 SSI 的发生率。使用随机效应模型，并报告汇总估计值为比值比（OR），相应的 95%置信区间（CI）。事先计划了按切口类型进行亚组分析。
最终分析纳入了 15 项 RCT，共纳入 6979 例患者。纳入的研究质量为中等到高。庆大霉素-胶原蛋白植入物显著降低 SSI 的发生率[OR=0.51；95%CI：0.33-0.77；P=0.001；需要治疗的人数（NNT）=21；I=75%]。在清洁（OR=0.53；95%CI：0.33-0.87；P=0.01；NNT=30）和清洁污染手术（OR=0.43；95%CI：0.20-0.93；P=0.03；NNT=9）的亚组分析中也观察到了这些结果。
庆大霉素-胶原蛋白植入物可降低 SSI 的发生率。
