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)

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

Study Overview

• Status: Unknown
• Conditions: Surgical Site Infection
• Intervention / Treatment: Procedure: Change of gloves and sterile instruments

Detailed Description

Internal Pilot

The aim of the 12-month internal pilot is to assess:

1. whether hospitals adhere to their allocation
2. 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: Interventional
• Enrollment (Anticipated): 12800
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention; Change of gloves and use of separate, sterile instruments before closing the abdominal wall	Procedure: Change of gloves and sterile instruments; 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	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	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	Unexpected re-admission into hospital for a wound-related problem within 30-days post surgery	within 30-days post-surgery
Length of hospital stay	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)	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	within 30 days of surgery	within 30 days post-surgery

Collaborators and Investigators

• Sponsor: University of Birmingham
• Investigators: Principal Investigator: Mr Aneel Bhangu, University of Birmingham

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: June 3, 2019
• First Submitted That Met QC Criteria: June 7, 2019
• First Posted (Actual): June 10, 2019

Study Record Updates

• Last Update Posted (Actual): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 23, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Wound Infection; Infections; Communicable Diseases; Surgical Wound Infection
• Other Study ID Numbers: 1234 (Department of Defense)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No