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)
Bibliographic record
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.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.007 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".