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

Primary Purpose

Surgical Site Infection

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Change of gloves and sterile instruments
Sponsored by
University of Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Surgical Site Infection

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    No Intervention

    Arm Label

    Intervention

    Current routine hospital practice

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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
    Re-admission
    Unexpected re-admission into hospital for a wound-related problem within 30-days post surgery
    Length of hospital stay
    Length of hospital stay following surgery
    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.
    Death
    within 30 days of surgery

    Full Information

    First Posted
    June 3, 2019
    Last Updated
    April 23, 2020
    Sponsor
    University of Birmingham
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03980652
    Brief Title
    Cheetah - Sterile Glove and Clean Instrument Change at the Time of Wound Closure to Reduce Surgical Site Infection
    Acronym
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2020 (Anticipated)
    Primary Completion Date
    June 2021 (Anticipated)
    Study Completion Date
    December 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Birmingham

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Surgical Site Infection

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Cluster randomised controlled trial
    Masking
    Participant
    Masking Description
    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
    Allocation
    Randomized
    Enrollment
    12800 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Other
    Arm Description
    Change of gloves and use of separate, sterile instruments before closing the abdominal wall
    Arm Title
    Current routine hospital practice
    Arm Type
    No Intervention
    Arm Description
    No change of gloves or use of separate, sterile instruments before closing the abdominal wall
    Intervention Type
    Procedure
    Intervention Name(s)
    Change of gloves and sterile instruments
    Intervention Description
    Change of gloves and use of separate , sterile instruments before closing the abdominal wall
    Primary Outcome Measure Information:
    Title
    Surgical Site Infection (SSI) at 30-days post-surgery
    Description
    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 Outcome Measure Information:
    Title
    SSI before discharge from hospital
    Description
    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
    Title
    Re-admission
    Description
    Unexpected re-admission into hospital for a wound-related problem within 30-days post surgery
    Time Frame
    within 30-days post-surgery
    Title
    Length of hospital stay
    Description
    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
    Title
    Return to normal activities e.g (work, school, or family duties)
    Description
    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.
    Title
    Death
    Description
    within 30 days of surgery
    Time Frame
    within 30 days post-surgery

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Donna Smith
    Phone
    +44(0)121 415 9103
    Email
    cheetah@trials.bham.ac.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mr Aneel Bhangu
    Organizational Affiliation
    University of Birmingham
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35264227
    Citation
    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. Erratum In: Trials. 2022 Apr 15;23(1):320.
    Results Reference
    derived

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

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