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

Study Overview
=================
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

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)

Conditions
-----------------
Surgical Site Infection

Intervention / Treatment
-----------------
* Procedure: Change of gloves and sterile instruments


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster randomised controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention<br>Change of gloves and use of separate, sterile instruments before closing the abdominal wall | Procedure: Change of gloves and sterile instruments<br>* Change of gloves and use of separate , sterile instruments before closing the abdominal wall<br>|
| No Intervention: Current routine hospital practice<br>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 |