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

Not Applicable
Conditions
Surgical Site Infection
Interventions
Procedure: Change of gloves and sterile instruments
Registration Number
NCT03980652
Lead Sponsor
University of Birmingham
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

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
12800
Inclusion Criteria

Not provided

Exclusion Criteria

• Patients undergoing caesarean section

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
InterventionChange of gloves and sterile instrumentsChange of gloves and use of separate, sterile instruments before closing the abdominal wall
Primary Outcome Measures
NameTimeMethod
Surgical Site Infection (SSI) at 30-days post-surgery30-days post-surgery

The Centre for Disease Control (CDC) definition will be used in ChEETAh to identify deep incisional or superficial incisional SSIs

Secondary Outcome Measures
NameTimeMethod
Length of hospital stayLength of hospital stay for the index operation and assessed at the point of discharge up to 30 days

Length of hospital stay following surgery

Return to normal activities e.g (work, school, or family duties)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.

SSI before discharge from hospitalup 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

Re-admissionwithin 30-days post-surgery

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

Deathwithin 30 days post-surgery

within 30 days of surgery

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