Lancet. 2022 Nov 19;400(10365):1767-1776. doi: 10.1016/S0140-6736(22)01884-0. Epub 2022 Oct 31.
Surgical site infection (SSI) remains the most common complication of surgery around the world. WHO does not make recommendations for changing gloves and instruments before wound closure owing to a lack of evidence. This study aimed to test whether a routine change of gloves and instruments before wound closure reduced abdominal SSI.
ChEETAh was a multicentre, cluster randomised trial in seven low-income and middle-income countries (Benin, Ghana, India, Mexico, Nigeria, Rwanda, South Africa). Any hospitals (clusters) doing abdominal surgery in participating countries were eligible. Clusters were randomly assigned to current practice (42) versus intervention (39; routine change of gloves and instruments before wound closure for the whole scrub team). Consecutive adults and children undergoing emergency or elective abdominal surgery (excluding caesarean section) for a clean-contaminated, contaminated, or dirty operation within each cluster were identified and included. It was not possible to mask the site investigators, nor the outcome assessors, but patients were masked to the treatment allocation. The primary outcome was SSI within 30 days after surgery (participant-level), assessed by US Centers for Disease Control and Prevention criteria and on the basis of the intention-to-treat principle. The trial has 90% power to detect a minimum reduction in the primary outcome from 16% to 12%, requiring 12 800 participants from at least 64 clusters. The trial was registered with ClinicalTrials.gov, NCT03700749.
Between June 24, 2020 and March 31, 2022, 81 clusters were randomly assigned, which included a total of 13 301 consecutive patients (7157 to current practice and 6144 to intervention group). Overall, 11 825 (88·9%) of 13 301 patients were adults, 6125 (46·0%) of 13 301 underwent elective surgery, and 8086 (60·8%) of 13 301 underwent surgery that was clean-contaminated or 5215 (39·2%) of 13 301 underwent surgery that was contaminated-dirty. Glove and instrument change took place in 58 (0·8%) of 7157 patients in the current practice group and 6044 (98·3%) of 6144 patients in the intervention group. The SSI rate was 1280 (18·9%) of 6768 in the current practice group versus 931 (16·0%) of 5789 in the intervention group (adjusted risk ratio: 0·87, 95% CI 0·79-0·95; p=0·0032). There was no evidence to suggest heterogeneity of effect across any of the prespecified subgroup analyses. We did not anticipate or collect any specific data on serious adverse events.
This trial showed a robust benefit to routinely changing gloves and instruments before abdominal wound closure. We suggest that it should be widely implemented into surgical practice around the world.
National Institute for Health Research (NIHR) Clinician Scientist Award, NIHR Global Health Research Unit Grant, Mölnlycke Healthcare.
手术部位感染（SSI）仍是全球最常见的手术并发症。由于缺乏证据，世界卫生组织未就伤口缝合前更换手套和器械提出建议。本研究旨在测试伤口缝合前常规更换手套和器械是否能降低腹部手术部位感染的发生率。
ChEETAh是一项在七个低收入和中等收入国家（贝宁、加纳、印度、墨西哥、尼日利亚、卢旺达、南非）开展的多中心、整群随机试验。参与国任何进行腹部手术的医院（整群）均符合条件。整群被随机分配至当前做法组（42个）和干预组（39个；整个手术团队在伤口缝合前常规更换手套和器械）。在每个整群中，连续纳入接受急诊或择期腹部手术（不包括剖宫产）的成年和儿童患者，手术类型为清洁-污染手术、污染手术或脏污手术。无法对现场研究人员和结果评估人员设盲，但对患者隐瞒治疗分配情况。主要结局是术后30天内的手术部位感染（个体水平），根据美国疾病控制与预防中心的标准并基于意向性分析原则进行评估。该试验有90%的把握度检测到主要结局至少从16%降至12%，这需要至少64个整群的12800名参与者。该试验已在ClinicalTrials.gov注册，注册号为NCT03700749。
在2020年6月24日至2022年3月31日期间，81个整群被随机分配，共纳入13301例连续患者（7157例至当前做法组，6144例至干预组）。总体而言，13301例患者中有11825例（88.9%）为成年人，13301例中有6125例（46.0%）接受择期手术，13301例中有8086例（60.8%）接受清洁-污染手术，或13301例中有5215例（39.2%）接受污染-脏污手术。当前做法组7157例患者中有58例（0.8%）更换了手套和器械，干预组6144例患者中有6044例（98.3%）更换了手套和器械。当前做法组6768例患者中有1280例（18.9%）发生手术部位感染，干预组5789例患者中有931例（16.0%）发生手术部位感染（调整风险比：0.87，95%置信区间0.79 - 0.95；p = 0.0032）。在任何预先设定的亚组分析中，均未发现效应异质性的证据。我们未预期也未收集任何关于严重不良事件的具体数据。
本试验表明，腹部伤口缝合前常规更换手套和器械有显著益处。我们建议应在全球外科手术实践中广泛实施。
国家卫生研究院（NIHR）临床科学家奖、NIHR全球健康研究单位基金、莫林医疗保健公司。
