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Clinical Evaluation of Adults Undergoing Elective Surgery Utilizing Intraoperative Incisional Wound Irrigation

Surgical Site Infection

A 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

  • 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 Centre
Barrie, Ontario
Canada

Contact Study Team

Primary Contact

Dorotea Mutabdzic, MD

[email protected]
North York General Hospital
North York General Hospital
North York, Ontario
Canada

Contact Study Team

Primary Contact

David Smith, MD MSc

[email protected]
(416) 498-8458
Thunder Bay Regional Health Sciences Centre
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario
Canada

Contact Study Team

Primary Contact

Jessica Holland, MD

[email protected]
Shared Health Manitoba
Shared Health Manitoba
Winnipeg, Manitoba
Canada

Contact Study Team

Primary Contact

Megan Delisle, MD

[email protected]
London Health Sciences Centre
London Health Sciences Centre
London, Ontario
Canada

Contact Study Team

Backup Contact

Ken Leslie, MD

[email protected]
Primary Contact

Kelly Vogt, MD MSc

[email protected]
Health Sciences North
Health Sciences North
Sudbury, Ontario
Canada

Contact Study Team

Primary Contact

Grace Ma, MD

[email protected]
St. Michael's Hospital
St. Michael's Hospital
Toronto, Ontario
Canada

Contact Study Team

Backup Contact

David Gomez, MD PhD

[email protected]
Primary Contact

Karim Ladha, MD MSc

[email protected]
Hamilton Health Sciences - Juravinski Hospital
Hamilton Health Sciences - Juravinski Hospital
Hamilton, Ontario
Canada

Contact Study Team

Primary Contact

Pablo Serrano, MD MSc MPH PhD

[email protected]
The Ottawa Hospital
The Ottawa Hospital
Ottawa, Ontario
Canada

Contact Study Team

Primary Contact

Jad Abou-Khalil, MD MSc

[email protected]
613-737-8899
Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Paul Karanicolas, MD PhD

[email protected]
416-480-4774
Kingston Health Sciences Centre
Kingston Health Sciences Centre
Kingston, Ontario
Canada

Contact Study Team

Primary Contact

Sean Bennett, MD MSc

[email protected]
Mackenzie Health
Mackenzie Health
Richmond Hill, Ontario
Canada

Contact Study Team

Primary Contact

Shahnoor Ullah, MD MSc

[email protected]
St. Joseph's Health Centre
St. Joseph's Health Centre
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Melanie Tsang, MD

[email protected]
Study Sponsored By
Sunnybrook Health Sciences Centre
Participants Required
More Information
Study ID: NCT04548661