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Efficacy and safety profile of antibiotic prophylaxis usage in clean and clean-contaminated plastic and reconstructive surgery: A meta-analysis of randomized controlled trials

机译:清洁和干净污染的整形和重建手术中抗生素预防使用的功效和安全性:随机对照试验的荟萃分析

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BACKGROUND: There is no consensus with regard to antibiotic prophylaxis usage in clean and clean-contaminated plastic and reconstructive surgery. This meta-analysis sought to assess the efficacy and safety of antibiotic prophylaxis and to determine appropriate duration of prophylaxis. METHODS: An English language literature search was conducted using PubMed and the Cochrane Collaboration for randomized controlled trials (RCTs) that evaluate the use of antibiotic prophylaxis to prevent postoperative surgical site infection (SSI) in patients undergoing clean and clean-contaminated plastic and reconstructive surgery. Data from intention-to-treat analyses were used where available. For the dichotomous data, results for each study were odds ratio (OR) with 95% confidence interval (CI) and combined for meta-analysis using the Mantel-Haenszel method or the DerSimonian and Laird method. Study quality was critically appraised by 2 reviewers using established criteria. STATA version 12 was used for meta-analyses. RESULTS: Twelve RCTs involving 2395 patients were included, of which 8 trials were considered to be of high methodological quality. Effect of antibiotic prophylaxis in plastic and reconstructive surgery was found favorable over placebo in SSI prevention (13 studies; 2449 participants; OR, 0.53; 95% CI, 0.4-0.7; P < 0.01) and the other wound complication (OWC) prevention (9 studies; 1843 participants; OR, 0.36; 95% CI, 0.15-0.84; P < 0.02). Subgroup analysis performed according to surgical wound type or the duration of prophylaxis did not modify the results except for the OWC with short-term antibiotic treatment. Compared with short-term antibiotic prophylaxis, long-term administration showed no evidence of a difference in risk of SSI (7 studies; 1012 participants; OR, 0.99; 95% CI, 0.63-1.55; P < 0.95), OWC (5 studies; 824 participants; OR, 0.92; 95% CI, 0.46-1.86; P < 0.82), and adverse event relative to antibiotic administration (3 studies; 653 participants; OR, 0.23; 95% CI, 0.01-4.92; P < 0.35). CONCLUSIONS: This meta-analysis of RCTs provides evidence supporting that antibiotic prophylaxis reduced postoperative SSI in clean plastic surgeries with high-risk factors and clean-contaminated plastic surgeries. Besides, a short-course administration regimen seemed to be of adequate efficacy and safety. High-quality prospective trials on larger scale are needed to further confirm these findings.
机译:背景:关于在干净和干净污染的整形和重建手术中使用抗生素预防尚无共识。这项荟萃分析旨在评估抗生素预防的有效性和安全性,并确定适当的预防时间。方法:使用PubMed和Cochrane协作进行了英语文献搜索,以进行随机对照试验(RCT),该试验评估了抗生素预防性使用在干净整洁的整形和重建手术患者中的预防术后手术部位感染(SSI)的能力。 。如果有意向,则使用意向分析数据。对于二分数据,每个研究的结果均为具有95%置信区间(CI)的比值比(OR),并使用Mantel-Haenszel方法或DerSimonian and Laird方法进行荟萃分析。 2名评价者使用既定标准对研究质量进行了严格评估。 STATA 12版用于荟萃分析。结果:纳入了12项RCT,涉及2395例患者,其中8项试验被认为具有较高的方法学质量。发现在SSI预防中,抗生素预防性整形和重建手术的效果优于安慰剂(13个研究; 2449名参与者; OR,0.53; 95%CI,0.4-0.7; P <0.01)和其他伤口并发症(OWC)的预防( 9个研究; 1843名参与者; OR,0.36; 95%CI,0.15-0.84; P <0.02)。根据手术伤口类型或预防时间进行的亚组分析除采用短期抗生素治疗的OWC以外,均未改变结果。与短期抗生素预防相比,长期给药未显示SSI风险差异的证据(7个研究; 1012名参与者; OR,0.99; 95%CI,0.63-1.55; P <0.95),OWC(5个研究) ; 824名参与者; OR,0.92; 95%CI,0.46-1.86; P <0.82),以及与抗生素管理相关的不良事件(3个研究; 653名参与者; OR,0.23; 95%CI,0.01-4.92; P <0.35 )。结论:这项对RCT的荟萃分析提供了证据,证明在高风险因素的清洁整形外科手术和清洁污染的整形外科手术中,抗生素的预防减少了术后SSI。此外,短期疗程似乎具有足够的疗效和安全性。需要大规模的高质量前瞻性试验来进一步证实这些发现。

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