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Surgical Site InfectionNCT04548661

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

A study testing Intraoperative incisional wound irrigation with povidone-iodine solution and Intraoperative incisional wound irrigation with saline in people with Surgical Site Infection, run by Sunnybrook Health Sciences Centre at 13 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Surgical Site Infection
What is being tested?
Intraoperative incisional wound irrigation with povidone-iodine solution and Intraoperative incisional wound irrigation with saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,701 participants
Where
13 sitesCanada
Study dates
2 Aug 2023to 30 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Canada13 sites

  • Royal Victoria Regional Health Centre

    Barrie, Ontario

  • Health Sciences North

    Greater Sudbury, Ontario, P3E 5J1

  • Hamilton Health Sciences - Juravinski Hospital

    Hamilton, Ontario

  • Kingston Health Sciences Centre

    Kingston, Ontario

  • London Health Sciences Centre

    London, Ontario

  • North York General Hospital

    North York, Ontario, M2K 1E1

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

  • Mackenzie Health

    Richmond Hill, Ontario

  • Thunder Bay Regional Health Sciences Centre

    Thunder Bay, Ontario

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • St. Joseph's Health Centre

    Toronto, Ontario

  • St. Michael's Hospital

    Toronto, Ontario

  • Shared Health Manitoba

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

About this study

Official title: CLinical Evaluation of Adults UNdergoing Elective Surgery Utilizing Intraoperative Incisional Wound Irrigation: A Randomized Controlled Trial (CLEAN Wound)

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.

Read the detailed description

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).

Being tested
Intraoperative incisional wound irrigation with povidone-iodine solution, Intraoperative incisional wound irrigation with saline
Keywords
Intraoperative incisional wound irrigation
Medical subject headings
Surgical Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intraoperative incisional wound irrigation with povidone-iodine solutionProcedure or surgery

    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.

  • Intraoperative incisional wound irrigation with salineProcedure or surgery

    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.

Study groups in NCT04548661
Study groupRoleWhat they receive
Povidone-iodine solutionExperimentalNot described
Receives: Procedure: Intraoperative incisional wound irrigation with povidone-iodine solution
SalinePlacebo comparatorNot described
Receives: Procedure: Intraoperative incisional wound irrigation with saline
No irrigationNo interventionStandard incision management

What is being measured

The primary outcome is the main question the study is designed to answer.

  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?)]

    Measured: Within 30 days of surgery

Secondary outcomes (8)

  1. EQ-5D-5L Quality of life

    The EQ-5D-5L (not an abbreviation) is a widely used generic measure of health status consisting of two parts. The first part (the descriptive system) assesses health in five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to). The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The second part of the questionnaire consists of a visual analogue scale (VAS) on which the patient rates their perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).

    Measured: within 30 days of surgery

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

    Measured: within 30 days of surgery

  3. Proportion of participants prescribed systemic antibiotics

    Measured: within 30 days of surgery

  4. Length of stay (LOS) (in days)

    Measured: during hospitalization (up to day 30)

  5. Proportion of participants with wound dehiscence requiring reoperation

    Measured: within 90 days of surgery

  6. Proportion of participants with postoperative complications

    Measured: within 90 days of surgery

  7. Mortality

    Measured: within 90 days of surgery

  8. Healthcare utilization

    1. Number of re-interventions (i.e. radiologically guided drain insertion or revision);
    2. Number of all-cause reoperations;
    3. Number of all-cause emergency department visits;
    4. Number of all-cause family physician or walk-in clinic visits; and
    5. Number of all-cause readmissions and length of stay of each readmission.

    Measured: within 90 days of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2020
  2. Study start2 Aug 2023
  3. Primary completion30 Sep 2025
  4. Study completion30 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Pragmatic, multicentre, participant and adjudicator-blinded, three-arm randomized controlled trial
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
2,701 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04548661
Sponsor's protocol ID
CTO Project ID 4304
Status last verified
Dec 2025
First submitted
8 Sep 2020
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40675632

Questions about this trial

What is this clinical trial studying?

A study testing Intraoperative incisional wound irrigation with povidone-iodine solution and Intraoperative incisional wound irrigation with saline in people with Surgical Site Infection, run by Sunnybrook Health Sciences Centre at 13 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of incisional surgical site infection (SSI) (time frame: Within 30 days of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04548661, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.

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