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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
Internal Pilot
The aim of the 12-month internal pilot is to assess:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Other | Change of gloves and use of separate, sterile instruments before closing the abdominal wall |
|
| Current routine hospital practice | No Intervention | No change of gloves or use of separate, sterile instruments before closing the abdominal wall |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Change of gloves and sterile instruments | Procedure | Change of gloves and use of separate , sterile instruments before closing the abdominal wall |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 30 days |
| Re-admission |
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Inclusion Criteria
Participant Exclusion Criteria:
• Patients undergoing caesarean section
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Donna Smith | Contact | +44(0)121 415 9103 | cheetah@trials.bham.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Mr Aneel Bhangu | University of Birmingham | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35264227 | Derived | 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. |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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Cluster randomised controlled trial
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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
Unexpected re-admission into hospital for a wound-related problem within 30-days post surgery
| within 30-days post-surgery |
| Length of hospital stay | Length of hospital stay following surgery | 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) | 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. | The assessment will be made up to 30-days from the index operation. |
| Death | within 30 days of surgery | within 30 days post-surgery |
| D013568 |
| Pathological Conditions, Signs and Symptoms |