Clinical trial NCT03980652: Cheetah - Sterile Glove and Clean Instrument Change at the Time of Wound Closure to Reduce Surgical Site Infection
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
Overall status: UNKNOWN
Phase: NA
Conditions: Surgical Site Infection
Lead sponsor: University of Birmingham
Sponsor class: OTHER
First posted: 2019-06-10
Enrollment: 12800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomised controlled trial
Primary purpose: OTHER

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:

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

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

Primary outcomes:
measure: Surgical Site Infection (SSI) at 30-days post-surgery
timeFrame: 30-days post-surgery
Secondary outcomes:
measure: SSI before discharge from hospital
timeFrame: up to 30 days
measure: Re-admission
timeFrame: within 30-days post-surgery
measure: Length of hospital stay
timeFrame: Length of hospital stay for the index operation and assessed at the point of discharge up to 30 days
measure: Return to normal activities e.g (work, school, or family duties)
timeFrame: The assessment will be made up to 30-days from the index operation.
measure: Death
timeFrame: within 30 days post-surgery
Other outcomes:
Locations:
Study officials:
affiliation: University of Birmingham
name: Mr Aneel Bhangu
role: PRINCIPAL_INVESTIGATOR
References:
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.