Cheetah - Sterile Glove and Clean Instrument Change at the Time of Wound Closure to Reduce Surgical Site Infection (Cheetah)
Primary Purpose
Surgical Site Infection
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Change of gloves and sterile instruments
Sponsored by
About this trial
This is an interventional other trial for Surgical Site Infection
Eligibility Criteria
Inclusion Criteria
- Countries: LMICs defined by the Development Assistance Committee (DAC) Official Development Assistance (ODA) list where there are at least 4 eligible hospitals per country in HIC-CHEETAH protocol (HICs are those that do not appear on the Organisation for Economic Co-operation and Development's Official Development Assistance (ODA) list
- Hospitals (clusters): in LMICs where glove and instrument change is not currently routine hospital practice
- Participants: Patients undergoing abdominal surgery who satisfy the following criteria are eligible:
- Emergency (surgery on an unplanned admission) or elective (surgery on a planned admission)
- Intraoperative finding of clean-contaminated, contaminated or dirty surgery
- with at least one abdominal incision that is ≥5cm
- Aged 16 years and over on the day of surgery (applicable to HIC-CHEETAH protocol only)
Participant Exclusion Criteria:
• Patients undergoing caesarean section
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Intervention
Current routine hospital practice
Arm Description
Change of gloves and use of separate, sterile instruments before closing the abdominal wall
No change of gloves or use of separate, sterile instruments before closing the abdominal wall
Outcomes
Primary Outcome Measures
Surgical Site Infection (SSI) at 30-days post-surgery
The Centre for Disease Control (CDC) definition will be used in ChEETAh to identify deep incisional or superficial incisional SSIs
Secondary Outcome Measures
SSI before discharge from hospital
SSI will be assessed following the index operation, at the point of discharge, and assessed according to the Centre for Disease Control (CDC) criteria
Re-admission
Unexpected re-admission into hospital for a wound-related problem within 30-days post surgery
Length of hospital stay
Length of hospital stay following surgery
Return to normal activities e.g (work, school, or family duties)
Return to normal activities from the date of the index operation will be assessed by a questionnaire via telephone and analysed by the Centre for Disease Control (CDC) criteria.
Death
within 30 days of surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03980652
Brief Title
Cheetah - Sterile Glove and Clean Instrument Change at the Time of Wound Closure to Reduce Surgical Site Infection
Acronym
Cheetah
Official Title
Cheetah - a Cluster Randomized Trial of Sterile Glove and Clean Instrument Change at the Time of Wound Closure to Reduce Surgical Site Infection (SSI). A Trial in Low and Middle Income Countries (LMICs) and A Trial in High Income Countries (HICs)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 2020 (Anticipated)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
Detailed Description
Internal Pilot
The aim of the 12-month internal pilot is to assess:
whether hospitals adhere to their allocation
what proportion of patients who are eligible for ChEETAh can be followed up successfully at 30 days after their surgery
Main Study
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster randomised controlled trial
Masking
Participant
Masking Description
The Randomisation is at the hospital level and hospitals will be randomised to the intervention (of separating sterile surgical instruments and gloves at the time of wound closure). Patients will not be made aware of the hospital/theatre randomisation, as patients would also not be aware of the specifics of any operation
Allocation
Randomized
Enrollment
12800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Other
Arm Description
Change of gloves and use of separate, sterile instruments before closing the abdominal wall
Arm Title
Current routine hospital practice
Arm Type
No Intervention
Arm Description
No change of gloves or use of separate, sterile instruments before closing the abdominal wall
Intervention Type
Procedure
Intervention Name(s)
Change of gloves and sterile instruments
Intervention Description
Change of gloves and use of separate , sterile instruments before closing the abdominal wall
Primary Outcome Measure Information:
Title
Surgical Site Infection (SSI) at 30-days post-surgery
Description
The Centre for Disease Control (CDC) definition will be used in ChEETAh to identify deep incisional or superficial incisional SSIs
Time Frame
30-days post-surgery
Secondary Outcome Measure Information:
Title
SSI before discharge from hospital
Description
SSI will be assessed following the index operation, at the point of discharge, and assessed according to the Centre for Disease Control (CDC) criteria
Time Frame
up to 30 days
Title
Re-admission
Description
Unexpected re-admission into hospital for a wound-related problem within 30-days post surgery
Time Frame
within 30-days post-surgery
Title
Length of hospital stay
Description
Length of hospital stay following surgery
Time Frame
Length of hospital stay for the index operation and assessed at the point of discharge up to 30 days
Title
Return to normal activities e.g (work, school, or family duties)
Description
Return to normal activities from the date of the index operation will be assessed by a questionnaire via telephone and analysed by the Centre for Disease Control (CDC) criteria.
Time Frame
The assessment will be made up to 30-days from the index operation.
Title
Death
Description
within 30 days of surgery
Time Frame
within 30 days post-surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Countries: LMICs defined by the Development Assistance Committee (DAC) Official Development Assistance (ODA) list where there are at least 4 eligible hospitals per country in HIC-CHEETAH protocol (HICs are those that do not appear on the Organisation for Economic Co-operation and Development's Official Development Assistance (ODA) list
Hospitals (clusters): in LMICs where glove and instrument change is not currently routine hospital practice
Participants: Patients undergoing abdominal surgery who satisfy the following criteria are eligible:
Emergency (surgery on an unplanned admission) or elective (surgery on a planned admission)
Intraoperative finding of clean-contaminated, contaminated or dirty surgery
with at least one abdominal incision that is ≥5cm
Aged 16 years and over on the day of surgery (applicable to HIC-CHEETAH protocol only)
Participant Exclusion Criteria:
• Patients undergoing caesarean section
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Donna Smith
Phone
+44(0)121 415 9103
Email
cheetah@trials.bham.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mr Aneel Bhangu
Organizational Affiliation
University of Birmingham
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
35264227
Citation
NIHR Global Health Research Unit on Global Surgery. 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). Trials. 2022 Mar 9;23(1):204. doi: 10.1186/s13063-022-06102-5. Erratum In: Trials. 2022 Apr 15;23(1):320.
Results Reference
derived
Learn more about this trial
Cheetah - Sterile Glove and Clean Instrument Change at the Time of Wound Closure to Reduce Surgical Site Infection
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