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Antiseptic

Wound Irrigation for Surgical Site Infection

N/A
Recruiting
Led By Paul Karanicolas, MD PhD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Scheduled to undergo any one of the following surgical procedures: 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 30 days of surgery
Awards & highlights

Study Summary

This trial is testing whether or not irrigating an open wound with a povidone-iodine solution before closing it up can help reduce the risk of surgical site infection.

Who is the study for?
This trial is for adults over 18 who are scheduled for certain abdominal or groin surgeries and have health insurance in Ontario. It's not for those with active infections, extremely dirty surgical sites, or allergies to povidone-iodine.Check my eligibility
What is being tested?
The CLEAN Wound trial tests if washing the surgery site with povidone-iodine antiseptic or saline can prevent infections within 30 days post-surgery compared to no washing at all. Participants will be randomly assigned to one of these three approaches.See study design
What are the potential side effects?
Potential side effects may include skin irritation or allergic reactions from povidone-iodine solution. Saline irrigation typically has minimal risk but could cause discomfort during application.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a specific surgery that is considered to be at risk of infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 30 days of surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 days of surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of incisional surgical site infection (SSI)
Secondary outcome measures
EQ-5D-5L Quality of life
Healthcare utilization
Length of stay (LOS) (in days)
+5 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Povidone-iodine solutionExperimental Treatment1 Intervention
Group II: No irrigationActive Control1 Intervention
Standard incision management
Group III: SalinePlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,548,808 Total Patients Enrolled
Paul Karanicolas, MD PhDPrincipal InvestigatorSunnybrook Health Sciences Centre
5 Previous Clinical Trials
1,795 Total Patients Enrolled

Media Library

Intraoperative incisional wound irrigation with povidone-iodine solution (Antiseptic) Clinical Trial Eligibility Overview. Trial Name: NCT04548661 — N/A
Surgical Site Infection Research Study Groups: Saline, No irrigation, Povidone-iodine solution

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Clinical Evaluation of Adults Undergoing Elective Surgery Utilizing Intraoperative Incisional Wound Irrigation
Dr. Paul Karanicolas 2023. "Clinical Evaluation of Adults Undergoing Elective Surgery Utilizing Intraoperative Incisional Wound Irrigation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04548661.
~1667 spots leftby Aug 2025
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