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

Surgical Site Infection Clinical Trial

— Cheetah  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03980652
• Other study ID #: 1234
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2020
• Est. completion date: December 2021

Study information

• Verified date: April 2020
• Source: University of Birmingham
• Contact: Donna Smith
• Phone: +44(0)121 415 9103
• Email: cheetah[@]trials.bham.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 12800
• Est. completion date: December 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Surgical Site Infection
• Surgical Wound Infection

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Birmingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Re-admission	Unexpected re-admission into hospital for a wound-related problem within 30-days post surgery	within 30-days post-surgery
Secondary	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
Secondary	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.
Secondary	Death	within 30 days of surgery	within 30 days post-surgery