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

• Sponsor: University of Birmingham (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03980652
• Collaborator: (none)
• Enrollment: 12,800
• Arms: 2
• Anticipated Duration (Months): 19

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Surgical Site Infection	Procedure: Change of gloves and sterile instruments	N/A

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12800 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Cluster randomised controlled trialCluster randomised controlled trial
• Masking: Single (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
• Primary Purpose: Other
• 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)
• Anticipated Study Start Date: May 1, 2020
• Anticipated Primary Completion Date: Jun 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Intervention Change of gloves and use of separate, sterile instruments before closing the abdominal wall	Procedure: Change of gloves and sterile instruments; Change of gloves and use of separate , sterile instruments before closing the abdominal wall
No Intervention: Current routine hospital practice No change of gloves or use of separate, sterile instruments before closing the abdominal wall

Outcome Measures

Primary Outcome Measures

1. Surgical Site Infection (SSI) at 30-days post-surgery [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

1. SSI before discharge from hospital [up 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

2. Re-admission [within 30-days post-surgery]

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

3. Length of hospital stay [Length of hospital stay for the index operation and assessed at the point of discharge up to 30 days]

   Length of hospital stay following surgery

4. 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.

5. Death [within 30 days post-surgery]

   within 30 days of surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Birmingham

Investigators

• Principal Investigator: Mr Aneel Bhangu, University of Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Birmingham
• ClinicalTrials.gov Identifier: NCT03980652
• Other Study ID Numbers: 1234
• First Posted: Jun 10, 2019
• Last Update Posted: Apr 24, 2020
• Last Verified: Apr 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection

Study Results

No Results Posted as of Apr 24, 2020