Study protocol for a cluster randomised trial of sterile glove and instrument change at the time of wound closure to reduce surgical site infection in low- and middle-income countries (CHEETAH)

Abstract

Background Surgical site infection (SSI) represents a major burden for patients, doctors, and health systems around the world. The aim of this trial is to assess whether the practice of using separate sterile gloves and instruments to close wounds at the end of surgery compared to current routine hospital practice can reduce surgical site infection at 30-days post-surgery for patients undergoing clean-contaminated, contaminated, or dirty abdominal surgery. Methods This study protocol describes a pragmatic, international, multi-centre, 2-arm, cluster randomised controlled trial, with an internal pilot. Clusters are defined as hospitals within low- and middle-income countries (LMICs) defined by the Development Assistance Committee (DAC) Official Development Assistance (ODA) list, where there are at least 4 eligible hospitals per country. Hospitals (clusters) must be in LMICs where glove and instrument change are not currently routine practice. Patients (adults and children) undergoing emergency or elective abdominal surgery for a clean-contaminated, contaminated, or dirty operation are eligible for inclusion. Before closing the abdominal wall, surgeons and the scrub nurse will change gloves and use separate, sterile instruments (intervention), versus no changing gloves or using separate, sterile instruments (standard practice, control). The primary outcome is SSI within 30 days after surgery, using the Centre for Disease Control (CDC) criteria. Secondary outcomes are SSI before point of hospital discharge, and readmission, reoperation, length of hospital stay, return to normal activities, and death up to 30-days after surgery. A 12-month internal pilot, including 12 clusters and approximately 600 participants, aims to assess adherence to allocation and follow-up of patients. The main trial is powered to detect a minimum reduction in the primary outcome from 16 to 12%. A total of 12,800 participants will be recruited from 64 clusters (hospitals) each including at least 200 participants. Discussion Change of gloves and sterile instruments prior to fascial closure in abdominal surgery is a low-cost, simple, intraoperative intervention which involves all members of the surgical and scrub team. If effective at reducing SSI, this practice could be readily implemented across all contexts. The findings of this trial will inform future guideline updates from international healthcare organisations, including the World Health Organization. Trial registration ClinicalTrials.gov NCT03980652. Registered on 9 July 2019

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

“…The protocol has been published. 13 A clusterrandomised trial design was chosen because contamination across groups would have been too common if individual patient randomisation was done. Clusters were defined as hospitals, participating from across seven LMICs (Benin, Ghana, India, Mexico, Nigeria, Rwanda, and South Africa).…”

“…4 From this, the group designed a protocol to test routine change of gloves and instruments before abdominal wound closure in 2018. 13 This intervention was selected as there was early signal of benefit, costs were likely to be low, and it was not practice at the time in collaborating hospitals. It was considered feasible to implement in resourceconstrained settings and, if effective, could be rapidly adopted to improve outcomes and optimise surgical systems.…”

Strategies to minimise and monitor biases and imbalances by arm in surgical cluster randomised trials: evidence from ChEETAh, a trial in seven low- and middle-income countries

“…ChEETAh was an international, multicentre, 2-arm, cRCT with an internal pilot [ 12 ]. It evaluated the use of separate sterile gloves and instruments before closing the abdominal wall to reduce the rate of surgical site infection in the 30 days after surgery.…”

“…Clusters were pseudo-anonymised by the use of a hospital ID for presentation in this analysis. Reporting of this process was pre-defined in the published study protocol [ 12 ]. Summary data were described using summary statistics in Stata V17.0 (Stata Corporation).…”

Correction: Study protocol for a cluster randomised trial of sterile glove and instrument change at the time of wound closure to reduce surgical site infection in low- and middle-income countries (CHEETAH)

“…Following the publication of the original article [ 1 ], we were notified that due to a misunderstanding during proofing, the authoring collaborator’s group was tagged as an affiliation instead of the main author.…”