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

NCT ID: NCT04548661

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2701 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-02

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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Background/Rationale: Recent international guidelines and reviews have highlighted that studies of intraoperative irrigation were conducted in small samples over 30 years ago and no longer reflect the standard of care, judging the evidence to be of very low to moderate quality, and have called for additional RCTs. For example, as per the WHO Guidelines, RCTs are needed to assess frequently utilized irrigation solutions and their effect on SSI risk and state that a suitable alternative to povidone-iodine is currently unknown. Furthermore, determining whether irrigation with antiseptics and antibiotics can reduce SSIs was listed as a key research recommendation by NICE, in addition to determining cost-effectiveness of the intervention. Additional evidence is therefore required to support or refute the effectiveness of intraoperative irrigation in reducing SSIs and to address practice heterogeneity, with a focus on establishing whether irrigation is needed, and if so, which solution should be used.

Objectives: The primary objective is to determine if intraoperative incisional wound irrigation with povidone-iodine or saline in participants undergoing surgery can reduce incisional SSIs within 30 days of surgery compared to no irrigation. The secondary outcomes include: quality of life (QoL), proportion of participants prescribed systemic antibiotics, wound care received via home care services (all within 30 days of surgery); length of stay (LOS) during index hospitalization; wound dehiscence requiring reoperation, postoperative complications, mortality and healthcare utilization (all within 90 days of surgery), including: number of re-interventions (i.e. radiologically guided drain insertion or revision); number of all-cause reoperations; number of all-cause emergency department visits; number of all-cause family physician or walk-in clinic visits; and number of all-cause readmissions and length of stay of each readmission.

Study Design: This is a multicentre, pragmatic, participant and adjudicator-blinded, three-arm RCT. Participants will be randomized using an adaptive design to incisional wound irrigation with povidone-iodine versus incisional wound irrigation with saline versus no irrigation and will be followed until 30 days after surgery to assess the incidence of SSIs, with additional outcomes collected up to 90 days after surgery. The trial is adaptive, in that one of the arms may be discontinued as the trial progresses if it reaches a threshold for inferiority, and will be a continuation of our pilot trial (i.e., a vanguard design).

Conditions

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Surgical Site Infection

Keywords

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Intraoperative incisional wound irrigation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pragmatic, multicentre, participant and adjudicator-blinded, three-arm randomized controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Povidone-iodine solution

Group Type EXPERIMENTAL

Intraoperative incisional wound irrigation with povidone-iodine solution

Intervention Type 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.

Saline

Group Type PLACEBO_COMPARATOR

Intraoperative incisional wound irrigation with saline

Intervention Type 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.

No irrigation

Standard incision management

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intraoperative incisional wound irrigation with povidone-iodine solution

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.

Intervention Type PROCEDURE

Intraoperative incisional wound irrigation with saline

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Dr. Paul Karanicolas

Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul Karanicolas, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

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Shared Health Manitoba

Winnipeg, Manitoba, Canada

Site Status

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada

Site Status

Health Sciences North

Greater Sudbury, Ontario, Canada

Site Status

Hamilton Health Sciences - Juravinski Hospital

Hamilton, Ontario, Canada

Site Status

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Site Status

London Health Sciences Centre

London, Ontario, Canada

Site Status

North York General Hospital

North York, Ontario, Canada

Site Status

The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status

Mackenzie Health

Richmond Hill, Ontario, Canada

Site Status

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, Canada

Site Status

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

St. Joseph's Health Centre

Toronto, Ontario, Canada

Site Status

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 40675632 (View on PubMed)

Other Identifiers

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CTO Project ID 4304

Identifier Type: -

Identifier Source: org_study_id