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

University of Birmingham

Status: Unknown

Conditions: Surgical Site Infection

Treatments: Procedure: Change of gloves and sterile instruments

Study type: Interventional

Funder types: Other

Identifiers

NCT03980652

1234

Details and patient eligibility

About

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

Full 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

Enrollment: 12,800 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12,800 participants in 2 patient groups

Intervention

Other group

Description:

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

Treatment:

Procedure: Change of gloves and sterile instruments

Current routine hospital practice

No Intervention group

Description:

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