Hadiati Diah R, Hakimi Mohammad, Nurdiati Detty S, da Silva Lopes Katharina, Ota Erika
Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, DR.Sardjito Hospital, Jl. Kesehatan No.1, Sekip, Yogyakarta, Daerah Istimewa Yogyakarta, Indonesia, 55281.
Cochrane Database Syst Rev. 2018 Oct 22;10(10):CD007462. doi: 10.1002/14651858.CD007462.pub4.
The risk of maternal mortality and morbidity (particularly postoperative infection) is higher for caesarean section (CS) than for vaginal birth. With the increasing rate of CS, it is important to minimise the risks to the mother as much as possible. This review focused on different forms and methods of preoperative skin preparation to prevent infection. This review is an update of a review that was first published in 2012, and updated in 2014.
To compare the effects of different antiseptic agents, different methods of application, or different forms of antiseptic used for preoperative skin preparation for preventing postcaesarean infection.
For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (27 November 2017), and reference lists of retrieved studies.
Randomised and quasi-randomised trials, evaluating any type of preoperative skin preparation agents, forms, and methods of application for caesarean section.Comparisons of interest in this review were between different antiseptic agents used for CS skin preparation (e.g. alcohol, povidone iodine), different methods of antiseptic application (e.g. scrub, paint, drape), different forms of antiseptic (e.g. powder, liquid), and also between different skin preparations, such as a plastic incisional drape, which may or may not be impregnated with antiseptic agents.Only studies involving the preparation of the incision area were included. This review did not cover studies of preoperative handwashing by the surgical team or preoperative bathing.
Three review authors independently assessed all potential studies for inclusion, assessed risk of bias, and extracted the data using a predesigned form. We checked data for accuracy. We assessed the quality of the evidence using the GRADE approach.
For this update, we included 11 randomised controlled trials (RCTs), with a total of 6237 women who were undergoing CS. Ten trials (6215 women) contributed data to this review. All included studies were individual RCTs. We did not identify any quasi- or cluster-RCTs. The trial dates ranged from 1983 to 2016. Six trials were conducted in the USA, and the remainder in Nigeria, South Africa, France, Denmark, and Indonesia.The included studies were broadly methodologically sound, but raised some specific concerns regarding risk of bias in a number of cases.Drape versus no drapeThis comparison investigated the use of a non-impregnated drape versus no drape, following preparation of the skin with antiseptics. For women undergoing CS, low-quality evidence suggested that using a drape before surgery compared with no drape, may make little or no difference to the incidence of surgical site infection (risk ratio (RR) 1.29, 95% confidence interval (CI) 0.97 to 1.71; 2 trials, 1294 women), or length of stay in the hospital (mean difference (MD) 0.10 day, 95% CI -0.27 to 0.46 1 trial, 603 women).One-minute alcohol scrub with iodophor drape versus five-minute iodophor scrub without drapeOne trial compared an alcohol scrub and iodophor drape with a five-minute iodophor scrub only, and reported no surgical site infection in either group (79 women, very-low quality evidence). We were uncertain whether the combination of a one-minute alcohol scrub and a drape reduced the incidence of endomyometritis when compared with a five-minute scrub, because the quality of the evidence was very low (RR 1.62, 95% CI 0.29 to 9.16; 1 trial, 79 women).Parachlorometaxylenol with iodine versus iodine aloneWe were uncertain whether parachlorometaxylenol with iodine before CS made any difference to the incidence of surgical site infection (RR 0.33, 95% CI 0.04 to 2.99; 1 trial, 50 women), or endometritis (RR 0.88, 95% CI 0.56 to 1.38; 1 trial, 50 women) when compared with iodine alone, because the quality of the evidence was very low.Chlorhexidine gluconate versus povidone iodineLow-quality evidence suggested that chlorhexidine gluconate before CS, when compared with povidone iodine, may make little or no difference to the incidence of surgical site infection (RR 0.80, 95% CI 0.62 to 1.02; 6 trials, 3607 women). However, surgical site infection appeared to be slightly reduced for women for whom chlorhexidine gluconate was used compared with povidone iodine after we removed four trials at high risk of bias for outcome assessment, in a sensitivity analysis (RR 0.59, 95% CI 0.37 to 0.95; 2 trials, 1321 women).Low-quality evidence indicated that chlorhexidine gluconate before CS, when compared with povidone iodine, may make little or no difference to the incidence of endometritis (RR 1.01, 95% CI 0.51 to 2.01; 2 trials, 2079 women), or to reducing maternal skin irritation or allergic skin reaction (RR 0.60, 95% CI 0.22 to 1.63; 2 trials, 1521 women).One small study (60 women) reported reduced bacterial growth at 18 hours after CS for women who had chlorhexidine gluconate preparation compared with women who had povidone iodine preparation (RR 0.23, 95% CI 0.07 to 0.70).None of the included trials reported on maternal mortality or repeat surgery.Chlorhexidine 0.5% versus 70% alcohol plus drapeOne trial, which was only available as an abstract, investigated the effect of skin preparation on neonatal adverse events, and found cord blood iodine concentration to be higher in the iodine group.
AUTHORS' CONCLUSIONS: There was insufficient evidence available from the included RCTs to fully evaluate different agents and methods of skin preparation for preventing infection following caesarean section. Therefore, it is not yet clear what sort of skin preparation may be most effective for preventing postcaesarean surgical site infection, or for reducing other undesirable outcomes for mother and baby.Most of the evidence in this review was deemed to be very low or low quality. This means that for most findings, our confidence in any evidence of an intervention effect is limited, and indicates the need for more high-quality research.This field needs high quality, well designed RCTs, with larger sample sizes. High priority questions include comparing types of antiseptic (especially iodine versus chlorhexidine), and application methods (scrubbing, swabbing, or draping). We found four studies that were ongoing; we will incorporate the results of these studies in future updates of this review.
剖宫产的孕产妇死亡和发病风险（尤其是术后感染）高于阴道分娩。随着剖宫产率的上升，尽可能降低对母亲的风险非常重要。本综述聚焦于术前皮肤准备的不同形式和方法以预防感染。本综述是对2012年首次发表并于2014年更新的综述的更新。
比较不同防腐剂、不同应用方法或不同形式的防腐剂用于剖宫产术前皮肤准备以预防剖宫产术后感染的效果。
对于本次更新，我们检索了Cochrane妊娠与分娩试验注册库、ClinicalTrials.gov、世界卫生组织国际临床试验注册平台（ICTRP）（2017年1月27日）以及检索到的研究的参考文献列表。
随机和半随机试验，评估剖宫产术前皮肤准备的任何类型的制剂、形式和应用方法。本综述感兴趣的比较包括用于剖宫产皮肤准备的不同防腐剂（如酒精、聚维酮碘）、不同的防腐剂应用方法（如擦洗、涂抹、铺巾）、不同形式的防腐剂（如粉末、液体），以及不同的皮肤准备之间，如可能含有或不含有防腐剂的塑料切口铺巾。仅纳入涉及切口区域准备的研究。本综述不包括手术团队术前洗手或术前沐浴的研究。
三位综述作者独立评估所有潜在纳入研究，评估偏倚风险，并使用预先设计的表格提取数据。我们检查数据的准确性。我们使用GRADE方法评估证据质量。
对于本次更新，我们纳入了11项随机对照试验（RCT），共有6237名接受剖宫产的妇女。10项试验（6215名妇女）为本综述提供了数据。所有纳入研究均为个体RCT。我们未识别到任何半随机或整群RCT。试验日期从1983年至2016年。6项试验在美国进行，其余在尼日利亚、南非、法国、丹麦和印度尼西亚进行。纳入研究在方法学上总体合理，但在一些情况下对偏倚风险提出了一些具体担忧。
该比较研究了在皮肤用防腐剂准备后使用未浸渍铺巾与不使用铺巾的情况。对于接受剖宫产的妇女，低质量证据表明，与不使用铺巾相比，术前使用铺巾可能对手术部位感染的发生率影响很小或无影响（风险比（RR）1.29，95%置信区间（CI）0.97至1.71；2项试验，1294名妇女），或对住院时间影响很小或无影响（平均差（MD）0.10天，95%CI -0.27至0.46；1项试验，603名妇女）。
一项试验比较了酒精擦洗和含碘附器与仅五分钟碘伏擦洗的情况，两组均未报告手术部位感染（79名妇女，极低质量证据）。我们不确定与五分钟擦洗相比，一分钟酒精擦洗和铺巾的组合是否能降低子宫内膜炎的发生率，因为证据质量非常低（RR 1.62，95%CI 0.2至9.16；1项试验，79名妇女）。
我们不确定剖宫产术前对氯间二甲苯酚加碘与单独碘相比，对手术部位感染的发生率（RR 0.33，95%CI 0.04至2.99；1项试验，50名妇女）或子宫内膜炎的发生率（RR 0.88，95%CI 0.56至1.38；1项试验，50名妇女）是否有任何差异，因为证据质量非常低。
低质量证据表明，剖宫产术前葡萄糖酸氯己定与聚维酮碘相比，对手术部位感染的发生率可能影响很小或无影响（RR 0.80，95%CI 0.62至1.02；6项试验，3607名妇女）。然而，在敏感性分析中，在去除4项结局评估存在高偏倚风险的试验后，与聚维酮碘相比，使用葡萄糖酸氯己定的妇女手术部位感染似乎略有降低（RR 0.59，95%CI 0.37至0.95；2项试验，1321名妇女）。低质量证据表明，剖宫产术前葡萄糖酸氯己定与聚维酮碘相比，对子宫内膜炎的发生率（RR 1.01，95%CI 0.51至2.01；2项试验，2079名妇女）或对减少产妇皮肤刺激或过敏性皮肤反应（RR 0.60，95%CI 0.22至1.63；2项试验，1521名妇女）可能影响很小或无影响。一项小型研究（60名妇女）报告，与使用聚维酮碘准备的妇女相比，使用葡萄糖酸氯己定准备的妇女在剖宫产术后18小时细菌生长减少（RR 0.23，95%CI 0.07至0.70）。
纳入的试验均未报告孕产妇死亡率或再次手术情况。
0.5%氯己定与70%酒精加铺巾：一项仅以摘要形式提供的试验研究了皮肤准备对新生儿不良事件的影响，发现碘组脐带血碘浓度较高。
纳入的随机对照试验提供的证据不足，无法全面评估剖宫产术后预防感染的不同皮肤准备制剂和方法。因此，尚不清楚哪种皮肤准备可能最有效地预防剖宫产术后手术部位感染，或减少对母婴的其他不良结局。本综述中的大多数证据被认为质量极低或低。这意味着对于大多数研究结果，我们对任何干预效果证据的信心有限，表明需要更多高质量的研究。该领域需要高质量、设计良好且样本量更大的随机对照试验。高度优先的问题包括比较防腐剂类型（尤其是碘与氯己定）和应用方法（擦洗、擦拭或铺巾）。我们发现有4项研究正在进行；我们将在本综述的未来更新中纳入这些研究的结果。
