Cheetah - Sterile Glove and Clean Instrument Change at the Time of Wound Closure to Reduce Surgical Site Infection

University of Birmingham12,800 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

12,800

Conditions

Surgical Site Infection

Interventions

Change of gloves and sterile instrumentsPROCEDURE

Change of gloves and use of separate , sterile instruments before closing the abdominal wall

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 30-days post-surgery

Secondary Outcomes

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

Time frame: up to 30 days

Re-admission

Unexpected re-admission into hospital for a wound-related problem within 30-days post surgery

Time frame: within 30-days post-surgery

Length of hospital stay

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

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.

Time frame: The assessment will be made up to 30-days from the index operation.

Death

within 30 days of surgery

Time frame: within 30 days post-surgery

Central Contacts

Donna Smith

CONTACT

+44(0)121 415 9103 cheetah@trials.bham.ac.uk

Data from ClinicalTrials.gov

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