Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202008463834676 Date of Approval: 20/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title 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 (LMICs)
Official scientific title 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 (LMICs)
Brief summary describing the background and objectives of the trial Aim: 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. Design: International, multicentre, 2-arm, cluster randomised controlled trial, with an internal pilot. Clusters are defined as hospitals. Eligibility: 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): in LMICs where glove and instrument change is not currently routine hospital practice. Participants: Patients (adults and children) undergoing emergency or elective abdominal surgery for a clean-contaminated, contaminated, or dirty operation. Interventions: Before closing the abdominal wall, surgeons and the scrub nurse will change gloves and use separate, sterile instruments, versus current routine hospital practice (of not changing gloves or using separate, sterile instruments). Outcomes: The primary outcome is SSI 30 days post-surgery, using the Centre for Disease Control (CDC) criteria. Secondary outcomes are SSI before point of hospital discharge, readmission (within 30-days post-surgery), reoperation (within 30-days post-surgery), length of hospital stay, return to normal activities and death (within 30 days of surgery).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CHEETAH
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Change of sterile gloves and sterile set of instruments for abdominal wound closure
Anticipated trial start date 01/01/2020
Actual trial start date 03/02/2020
Anticipated date of last follow up 04/01/2021
Actual Last follow-up date 23/06/2022
Anticipated target sample size (number of participants) 12800
Actual target sample size (number of participants) 12800
Recruitment status Completed
Publication URL https://www.thelancet.com/article/S0140-6736(22)01884-0/fulltext
Secondary Ids Issuing authority/Trial register
Case Report Form Ghana Health Service
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Change of sterile gloves and sterile set of instruments for abdominal wound closure N/A 30 day follow-up Change of sterile gloves and sterile set of instruments for abdominal wound closure 6400
Experimental Group Change of sterile gloves and sterile set of instruments for abdominal wound closure 30-day follow up after surgery Change of sterile gloves and sterile set of instruments for abdominal wound closure 6400
Control Group No Changing of sterile gloves and sterile set of instruments for abdominal wound closure 30-day follow up after abdominal Surgery Changing of sterile gloves and sterile set of instruments for abdominal wound closure 6400 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Hospital Inclusion Criteria 1. Hospitals where glove and instrument change is not currently routine practice. Patient Inclusion Criteria Patients undergoing abdominal surgery who satisfy the following criteria are eligible: 1a. Emergency (surgery on an unplanned admission) or elective (surgery on a planned admission) 1b. Intraoperative finding of clean-contaminated, contaminated or dirty surgery. 1c. With at least one abdominal incision that is ≥5cm Patients undergoing caesarean section. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 5 Year(s) 90 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 31/03/2020 Ghana Health Service
Ethics Committee Address
Street address City Postal code Country
Accra High Street Accra 00233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Surgical Site Infection 30-day postoperation
Secondary Outcome 1. SSI before discharge from hospital. 2. Unexpected re-admission into hospital for a wound-related problem within 30-days post surgery. 3. Unexpected re-operation for a wound-related problem within 30-days post surgery. 4. Length of hospital stay. 5. Return to normal activities (e.g. work, school, or family duties) within 30-days post surgery. 6. Death within 30 days of surgery 30 days of surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tamale Teaching Hopsital Hospital Road Tamale 00233 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
NIHR UK University of Birmingham Birmingham 0044 United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor University of Birmingham Edgabaston Birmingham 0044 United Kingdom Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Cape Coast Teaching Hospital Kotokroba Cape Coast 00233 Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Stephen Tabiri stabiri@uds.edu.gh +233201691005 Hospital Road
City Postal code Country Position/Affiliation
Tamale 00233 Ghana School of Medicine and Health SciencesUniversity for Development Studies and Tamale Teaching Hospital
Role Name Email Phone Street address
Public Enquiries Bernard Appiah Ofori benfora@gmail.com +233208310005 UDS Credit Union House
City Postal code Country Position/Affiliation
Tamale 00233 Ghana Global Surgery Ghana HUB
Role Name Email Phone Street address
Scientific Enquiries Francis Abantanga frankabantanga@hotmail.com +233208168700 University for Development Studies Dungu Campus
City Postal code Country Position/Affiliation
Tamale 00233 Ghana School of Medicine and Health SciencesUniversity for Development Studies and Tamale Teaching Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol One year after the end recruitment Publications: 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
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://ichgcp.net/clinical-trials-registry/NCT03980652 Yes 21/09/2023 31/10/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 21/09/2023 Result - 21/09/2023 Result - 21/09/2023 Result - 21/09/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06102-5
Changes to trial information