Surgical Site Infection
Conditions
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: 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
Interventions
PROCEDUREChange of gloves and sterile instruments
Change of gloves and use of separate , sterile instruments before closing the abdominal wall
Sponsors
University of Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
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
Intervention model description
Cluster randomised controlled trial
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Re-admission | within 30-days post-surgery | Unexpected re-admission into hospital for a wound-related problem 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 | Length of hospital stay following surgery |
| 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. |
| Death | within 30 days post-surgery | within 30 days of surgery |
Contacts
Primary ContactDonna Smith
Outcome results
None listed