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

NCT04548661 | Completed

• 1 other identifier: CTO Project ID 4304
• Study Type: interventional
• Target: 2,701
• Locations: 1 country
• Sites: 13

Brief Summary

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.

Conditions

Surgical Site Infection

Keywords

Intraoperative incisional wound irrigation

Outcome Measures

Primary Outcomes (1)

• Incidence of incisional surgical site infection (SSI)

  SSI will be captured through blinded central review of postoperative healthcare records and participants' self-report (using a patient-reported outcome measure, or PROM). Participants will be considered to have a SSI if they meet either the health record review criteria (if any of the following occurred: 1) wound was opened and packed; 2) wound-specific treatment with antibiotics; or 3) a diagnosis of SSI explicitly recorded in medical record by treating clinician) OR PROM criteria \[(i.e., if participant answers "Yes" to questions 2, 3 or 4: Have your surgical incision(s) been opened and packed (with gauze or bandages inside the wound) by a physician, physician assistant, nurse or nurse practitioner?; Have you been prescribed antibiotics for a problem with your surgical incision(s)?; Have you been told that your surgical incision(s) are infected by a physician, physician assistant, nurse or nurse practitioner?)\]

  Within 30 days of surgery

Secondary Outcomes (8)

• EQ-5D-5L Quality of life

  within 30 days of surgery

• Proportion of participants requiring wound care (received via home care services)

  within 30 days of surgery

• Proportion of participants prescribed systemic antibiotics

  within 30 days of surgery

• Length of stay (LOS) (in days)

  during hospitalization (up to day 30)

• Proportion of participants with wound dehiscence requiring reoperation

  within 90 days of surgery

Study Arms (3)

Povidone-iodine solution

EXPERIMENTAL

Procedure: Intraoperative incisional wound irrigation with povidone-iodine solution

Saline

PLACEBO COMPARATOR

Procedure: Intraoperative incisional wound irrigation with saline

No irrigation

NO INTERVENTION

Standard incision management

Interventions

Intraoperative incisional wound irrigation with saline PROCEDURE

Participants randomized to the saline irrigation group will have all incisions irrigated once with 0.9% sterile normal saline delivered through a bulb syringe. Irrigation will be performed after any/all deep tissue layers are closed, prior to skin closure. The volume used will be left to the discretion of the clinician and irrigation will be administered until saturation is achieved.

Saline

Intraoperative incisional wound irrigation with povidone-iodine solution PROCEDURE

Participants randomized to the povidone-iodine irrigation group will have all incisions irrigated once with povidone-iodine diluted in 0.9% sterile normal saline (to a final concentration of 5% povidone-iodine (0.5% available iodine)) delivered through a bulb syringe. The povidone-iodine irrigation should be left on for 60 seconds and then dried with sterile gauze. Irrigation will be performed after any/all deep tissue layers are closed, prior to skin closure. The volume used will be left to the discretion of the clinician and irrigation will be administered until saturation is achieved.

Povidone-iodine solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older;
• Ontario Health Insurance Plan (OHIP) holder (for Ontario sites)
• And planned 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

You may not qualify if:

• Contraindication to receiving povidone-iodine irrigation (i.e., known allergy)
• Any active skin or soft tissue infection (at any site, including gangrene)
• Known or anticipated CDC Class IV (Dirty) incision

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (13)

Shared Health Manitoba

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada

Location

Health Sciences North

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Hamilton Health Sciences - Juravinski Hospital

Hamilton, Ontario, Canada

Location

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

North York General Hospital

North York, Ontario, M2K 1E1, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Mackenzie Health

Richmond Hill, Ontario, Canada

Location

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Joseph's Health Centre

Toronto, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Related Publications (1)

• Roke R, Lillie E, Daneman N, Mason SA, Tomlinson G, Jiang Y, Shiroky J, Puran S, Smith DE, Abou Khalil J, Kayssi A, Serrano PE, Pinchuk B, Apte SS, Lamb T, Ma G, Vogt K, Leslie K, Mutabdzic D, Gomez D, Ladha KS, Tsang M, Bennett S, Ullah SM, Holland J, Delisle M, Smith AJ, Calderone M, Herriott J, Voltan E, Sloan B, Muaddi H, Fergusson DA, Mazer CD, Kennedy E, Marshall JC, Aarts MA, Nathens AB, Karanicolas PJ. Clinical evaluation of adults undergoing elective surgery utilizing intraoperative incisional wound irrigation (CLEAN Wound): protocol for a randomised controlled trial. BMJ Open. 2025 Jul 17;15(7):e104375. doi: 10.1136/bmjopen-2025-104375.

  PMID: 40675632 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Paul Karanicolas, MD PhD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Model Details: Pragmatic, multicentre, participant and adjudicator-blinded, three-arm randomized controlled trial

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 14, 2020
• Study Start: August 2, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (13)