- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03980652
Cheetah - Sterile Glove and Clean Instrument Change at the Time of Wound Closure to Reduce Surgical Site Infection (Cheetah)
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 Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Donna Smith
- Phone Number: +44(0)121 415 9103
- Email: cheetah@trials.bham.ac.uk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Intervention
Change of gloves and use of separate, sterile instruments before closing the abdominal wall
|
Change of gloves and use of separate , sterile instruments before closing the abdominal wall
|
No Intervention: Current routine hospital practice
No change of gloves or use of separate, sterile instruments before closing the abdominal wall
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Surgical Site Infection (SSI) at 30-days post-surgery
Time Frame: 30-days post-surgery
|
The Centre for Disease Control (CDC) definition will be used in ChEETAh to identify deep incisional or superficial incisional SSIs
|
30-days post-surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SSI before discharge from hospital
Time Frame: up to 30 days
|
SSI will be assessed following the index operation, at the point of discharge, and assessed according to the Centre for Disease Control (CDC) criteria
|
up to 30 days
|
Re-admission
Time Frame: within 30-days post-surgery
|
Unexpected re-admission into hospital for a wound-related problem within 30-days post surgery
|
within 30-days post-surgery
|
Length of hospital stay
Time Frame: Length of hospital stay for the index operation and assessed at the point of discharge up to 30 days
|
Length of hospital stay following surgery
|
Length of hospital stay for the index operation and assessed at the point of discharge up to 30 days
|
Return to normal activities e.g (work, school, or family duties)
Time Frame: The assessment will be made up to 30-days from the index operation.
|
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.
|
The assessment will be made up to 30-days from the index operation.
|
Death
Time Frame: within 30 days post-surgery
|
within 30 days of surgery
|
within 30 days post-surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mr Aneel Bhangu, University of Birmingham
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1234 (Other Identifier: Department of Defense)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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