Clinical Evaluation of Adults Undergoing Elective Surgery Utilizing Intraoperative Incisional Wound Irrigation
Surgical Site InfectionA surgical site infection (SSI) is an infection that occurs after a surgical procedure. Despite a variety of infection prevention strategies, SSIs still occur often and impose a significant burden on patients and the healthcare system. Intraoperative irrigation (or washing of the surgical incision before closure) may reduce SSIs, but this is uncertain.
The Clinical Evaluation of Adults Undergoing Elective Surgery Utilizing Intraoperative Incisional Wound Irrigation (CLEAN Wound) trial aims to determine if incisional wound irrigation with an antiseptic or salt water solution can reduce SSIs within 30 days of surgery compared to no wound irrigation. 2,500 patients aged 18 years or older who are planned to undergo an abdominal or groin open or laparoscopic procedure will be randomly assigned to incisional wound irrigation with povidone-iodine solution; or incisional wound irrigation with saline; or no irrigation and followed for 30 days after surgery to assess the incidence of SSIs, with additional outcomes collected up to 90 days after surgery.
Even with significant advances in medicine over the past decades, there are still many fundamental issues in perioperative care that remain unclear due to lack of evidence. If this trial were to demonstrate that intraoperative wound irrigation reduces the incidence of SSI, these practice-changing findings could greatly benefit patients worldwide.
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Participation Requirements
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Sex:
ALL -
Eligible Ages:
18 and up
Participation Criteria
All participants must meet all of the following inclusion criteria to participate in this study:
1. Aged 18 years or older;
2. Ontario Health Insurance Plan (OHIP) holder (for Ontario sites)
And planned to undergo any one of the following surgical procedures:
3. a) Laparotomy, CDC Class II (clean-contaminated) or III (contaminated) incision b) Laparoscopy with a planned extraction site ≥3 cm, CDC Class II (clean-contaminated) or III (contaminated) incision c) Groin incision for open or hybrid arterial procedure
All participants meeting any of the following exclusion criteria at baseline will be excluded from participation in this study:
1. Contraindication to receiving povidone-iodine irrigation (i.e., known allergy)
2. Any active skin or soft tissue infection (at any site, including gangrene)
3. Known or anticipated CDC Class IV (Dirty) incision
Study Location
Royal Victoria Regional Health Centre
Royal Victoria Regional Health CentreBarrie, Ontario
Canada
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North York General Hospital
North York General HospitalNorth York, Ontario
Canada
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Thunder Bay Regional Health Sciences Centre
Thunder Bay Regional Health Sciences CentreThunder Bay, Ontario
Canada
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Shared Health Manitoba
Shared Health ManitobaWinnipeg, Manitoba
Canada
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London Health Sciences Centre
London Health Sciences CentreLondon, Ontario
Canada
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Health Sciences North
Health Sciences NorthSudbury, Ontario
Canada
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St. Michael's Hospital
St. Michael's HospitalToronto, Ontario
Canada
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Hamilton Health Sciences - Juravinski Hospital
Hamilton Health Sciences - Juravinski HospitalHamilton, Ontario
Canada
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The Ottawa Hospital
The Ottawa HospitalOttawa, Ontario
Canada
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Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences CentreToronto, Ontario
Canada
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Kingston Health Sciences Centre
Kingston Health Sciences CentreKingston, Ontario
Canada
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Mackenzie Health
Mackenzie HealthRichmond Hill, Ontario
Canada
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St. Joseph's Health Centre
St. Joseph's Health CentreToronto, Ontario
Canada
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- Study Sponsored By
- Sunnybrook Health Sciences Centre
- Participants Required
- More Information
- Study ID:
NCT04548661