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

NCT03980652 | Unknown DMC

• 1 other identifier: 1234
• Study Type: interventional
• Target: 12,800
• Locations: 0 countries
• Sites: N/A

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

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• SSI before discharge from hospital

  up to 30 days

• Re-admission

  within 30-days post-surgery

• Length of hospital stay

  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)

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

• Death

  within 30 days post-surgery

Study Arms (2)

Intervention

OTHER

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

Procedure: Change of gloves and sterile instruments

Current routine hospital practice

NO INTERVENTION

No change of gloves or use of separate, sterile instruments before closing the abdominal wall

Interventions

Change of gloves and sterile instruments PROCEDURE

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

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Patients undergoing caesarean section

Sponsors & Collaborators

• University of Birmingham: lead

Related Publications (1)

• 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.

  PMID: 35264227 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mr Aneel Bhangu

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donna Smith

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The Randomisation is at the hospital level and hospitals will be randomised to the intervention (of separating sterile surgical instruments and gloves at the time of wound closure). Patients will not be made aware of the hospital/theatre randomisation, as patients would also not be aware of the specifics of any operation
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomised controlled trial

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 10, 2019
• Study Start: May 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 24, 2020

Record last verified: 2020-04