NIHR全球外科健康研究所分析了腹部伤口闭合时常规更换无菌手套和器械以防止手术部位感染的效果。2022年10月31日出版的《柳叶刀》杂志发表了这项成果。

手术部位感染（SSI）仍然是世界各地最常见的手术并发症。由于缺乏证据，世界卫生组织没有建议在伤口闭合前更换手套和器械。该研究旨在测试在伤口闭合前常规更换手套和器械是否会降低腹部SSI。

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）进行的多中心、集群随机试验。在参与国进行腹部手术的任何医院（集群）都符合资格。将集群随机分配到维持当前实践组（42）和干预组（39；整个擦洗团队在伤口闭合前常规更换手套和器械）。

在每个集群中，连续接受紧急或择期腹部手术（不包括剖腹产）的成人和儿童接受了清洁、污染或肮脏手术。现场研究人员和结果评估人员非盲，但患者对治疗分配盲。主要结局是手术后30天内的SSI（参与者水平），根据美国疾病控制和预防中心的标准和意向治疗原则进行评估。该试验有90%的能力可检测到主要结局从16%降至12%的最低限度，需要至少64个集群的12800名参与者。

2020年6月24日至2022年3月31日，81个集群被随机分配，包括13301名连续患者（当前实践组7157名，干预组6144名）。总的来说，13301名患者中有11825名（88.9%）是成年人，6125名（46.0%）接受了择期手术，8086名（60.8%）接受了清洁-污染的手术，5215人（39.2%）接受了污染-肮脏的手术。

当前实践组7157名患者中有58名（0.8%）发生了手套和器械更换，干预组6144名患者中6044名（98.3%）发生了更换。当前实践组的SSI率为6768人中有1280人（18.9%），而干预组为5789人中有931人（16.0%）（校正后的风险比为0.87，组间差异显著）。没有证据表明任何预先指定的亚组分析效果存在异质性。研究组没有预测或收集任何关于严重不良事件的具体数据。

这项试验表明，在腹部伤口闭合前定期更换手套和器械有很大的临床益处。研究组建议在世界各地的外科实践中广泛应用。

附：英文原文

Title: Routine sterile glove and instrument change at the time of abdominal wound closure to prevent surgical site infection (ChEETAh): a pragmatic, cluster-randomised trial in seven low-income and middle-income countries

Author: Adesoji O Ademuyiwa, Adewale O Adisa, Aneel Bhangu, Peter Brocklehurst, Sohini Chakrabortee, Dhruva Ghosh, James Glasbey, Parvez D Haque, Pollyanna Hardy, Ewen Harrison, JC Allen Ingabire, Lawani Ismail, Rachel Lillywhite, Laura Magill, Antonio Ramos de la Medina, Rachel Moore, Thomas Pinkney, Neil Winkles, Mark Monahan, Dion Morton, Dmitri Nepogodiev, Faustin Ntirenganya, Omar Omar, Joana Simoes, Donna Smith, Stephen Tabiri, Bryar Kadir, Lawani Ismail, Dhruva Ghosh, Antonio Ramos de la Medina, Rachel Moore, Faustin Ntirenganya, Stephen Tabiri, Pollyanna Hardy, Omar Omar, Felicity Brant, Elizabeth Li, Rachel Lillywhite, Maria Picciochi, Michael Bahrami-Hessari, Donna Smith, Emmy Runigamugabo, Didier Ahogni, Aristide Ahounou, K. Alassan Boukari, Oswald Gbehade, Thierry K Hessou, Sinama Nindopa, M.J. Bienvenue Nontonwanou, Nafissatou Orou Guessou, Arouna Sambo, Sorekou Victoire Tchati, Affisatou Tchogo, Semevo Romaric Tobome, Parfait Yanto, Isidore Gandaho, Armel Hadonou, Simplice Hinvo, Montcho Adrien Hodonou, Sambo Bio Tamou, Souliath Lawani, Covalic Melic Bokossa Kandokponou, Francis Moise Dossou, Antoine Gaou, Roland Goudou, Marie-Claire Kouroumta, Ismail Lawani, Enrif Malade, Anne Stredy Mkoh Dikao, Joel Nzuwa Nsilu, Pencome Ogouyemi, Marcelin Akpla, Nathan Bisimwa Mitima, Blaise Kovohouande, Cyrille Kpangon, Stephane Laurent Loupeda, Mamonde Victorin Agbangla, Sena Emmanuel Hedefoun, Thierry Mavoha, Juvenal Ngaguene, Janvier Rugendabanga, Rish Romaric Soton, Martin Totin, Mouhamed Agbadebo, Irene Akpo, Hubert Dewamon, Martin Djeto, Aissatou Hada, Monsede Hollo, Albert Houndji, Anasthasie Houndote, Sylvestre Hounsa, Expedit Kpatchassou, Hugues Yome, Mohamed Moussa Alidou, Eric Jerry Bara, B.T. Bonheur Dossou Yovo, Robert Guinnou, Souleymane Hamadou, H.Pauline Kola, Nabil Moussa, Boniface Cakpo, Lolyta Etchisse, Emery Hatangimana, Moise Muhindo, Katia Sanni, Agossou Barthelemy Yevide, Hermann Agossou, Fiston Basirwa Musengo, Hulrich Behanzin, Djifid Morel Seto, Bill Armstrong Alia, Arnaud Alitonou, Y.Edith Mehounou, Lucien Agbanda, Julien Attinon, Marcel Gbassi, Nounagnon Rene Hounsou, Regina Acquah, Charles Banka, Derick Esssien, Romeo Hussey, Yakubu Mustapha, Kojo Nunoo-Ghartey, Grace Yeboah, Margarey N M Adjei, Yvonne Adofo-Asamoah, Meshach M Agyapong, Thomas Agyen, Baba A B Alhassan, Mabel P Amoako-Boateng, Anthony Baffour Appiah, Josephine Ashong, Joseph K Awindaogo, Benjamin B Brimpong, Makafui S C J K Dayie, Donald Enti, Wendy W Ghansah, Jude E Gyamfi, Patience Koggoh, Richard Kpankpari, Vincent Kudoh, Samuel Mensah, Philip Mensah, Isabella N Morkor Opandoh, Martin T Morna, Michael Nortey, Emelia Odame

Issue&Volume: 2022-10-31

Abstract:

Background

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.

Methods

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 12800 participants from at least 64 clusters. The trial was registered with ClinicalTrials.gov, NCT03700749.

Findings

Between June 24, 2020 and March 31, 2022, 81 clusters were randomly assigned, which included a total of 13301 consecutive patients (7157 to current practice and 6144 to intervention group). Overall, 11825 (88·9%) of 13301 patients were adults, 6125 (46·0%) of 13301 underwent elective surgery, and 8086 (60·8%) of 13301 underwent surgery that was clean–contaminated or 5215 (39·2%) of 13301 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.

Interpretation

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.

DOI: 10.1016/S0140-6736(22)01884-0

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01884-0/fulltext