Trial Summary
What is the purpose of this trial?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.
What safety data exists for wound irrigation with povidone-iodine or saline?Several studies have evaluated the safety and effectiveness of wound irrigation with povidone-iodine and saline. A randomized controlled trial found that povidone-iodine significantly reduced surgical site infections compared to saline. Another study reported a lower incidence of wound infections with povidone-iodine irrigation. However, there are reports of povidone-iodine causing irritant contact dermatitis in some cases. Saline is considered safe and cost-effective, but further studies are needed to determine the optimal irrigation solution with low cytotoxic effects and good antimicrobial properties.15678
Do I need to stop my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is saline irrigation a promising treatment for preventing surgical site infections compared to povidone-iodine?Based on the research, povidone-iodine is more effective than saline in reducing surgical site infections. In several studies, povidone-iodine significantly decreased infection rates compared to saline. Therefore, saline irrigation is not as promising as povidone-iodine for preventing infections.12467
What data supports the idea that Wound Irrigation for Surgical Site Infection is an effective treatment?The available research shows mixed results for the effectiveness of wound irrigation with povidone-iodine compared to saline. One study found that using povidone-iodine significantly reduced wound infections compared to saline, with only 2.9% of patients experiencing infections versus 15.1% in the saline group. However, other studies did not find a significant benefit of povidone-iodine irrigation over saline, especially when not used with antibiotics. This suggests that while povidone-iodine can be more effective than saline in some cases, its effectiveness may depend on additional factors like the use of antibiotics.13467
Eligibility Criteria
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.Inclusion Criteria
I am scheduled for a specific surgery that is considered to be at risk of infection.
Exclusion Criteria
I do not have any active infections.
Treatment Details
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.
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
Intraoperative incisional wound irrigation with povidone-iodine solution is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Povidone-Iodine Solution for:
- Prevention of Surgical Site Infections (SSIs)
🇪🇺 Approved in European Union as Povidone-Iodine Solution for:
- Prevention of Surgical Site Infections (SSIs)
- Skin Disinfection
🇨🇦 Approved in Canada as Povidone-Iodine Solution for:
- Prevention of Surgical Site Infections (SSIs)
- Skin Disinfection
Find a clinic near you
Research locations nearbySelect from list below to view details:
Shared Health ManitobaWinnipeg, Canada
Health Sciences NorthSudbury, Canada
North York General HospitalNorth York, Canada
The Ottawa HospitalOttawa, Canada
More Trial Locations
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Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
References
Irrigation of subcutaneous tissue with povidone-iodine solution for prevention of surgical wound infections. [2017]Five hundred patients undergoing a variety of general surgical operative procedures were prospectively randomly allocated into a treatment group, in which the incisions were irrigated with povidone-iodine solution prior to skin closure or into a control group in which wounds were irrigated with saline solution. Wounds were classified according to the degree of bacterial contamination as clean, potentially contaminated, contaminated or dirty. For all categories of surgical incisions, povidone-iodine irrigation resulted in a significant decrease in wound infections over that for saline solution irrigation. Over-all incidence of wound sepsis in the treatment group was seven of 242 patients, 2.9 per cent, compared with the control rate of 39 wound infections of 258 patients, 15.1 per cent--p less than 0.001.
A trial of povidone-iodine in the prevention of infection in sutured lacerations. [2019]A prospective, randomized study of 500 consecutive emergency department patients with traumatic lacerations requiring sutures was performed comparing use of topical 1% povidone-iodine (Betadine) and scrubbing with wound management by irrigation with normal saline without scrubbing. A 60-second wound irrigation and scrub with a 1% povidone-iodine solution was the only difference in treatment between the two groups. Data relating to risk factors such as age; degree of contamination; type of closure; ethanol intoxication; mechanism of injury; and bone, joint, or tendon involvement were analyzed. Wounds were classified as clean, infected, or purulent at follow-up examination. One hundred five patients were lost to follow-up. Of the 395 remaining patients, 122 were contacted by phone and were classified based on their description of the wound; 273 were classified at reexamination in the ED. Of 201 povidone-iodine group wounds, 11 became infected; two of them (5.4%) were purulent. Of 194 control wounds, 30 became infected, of which 12 (15.46%) were purulent (P less than .01). These data suggest that use of a topical 1% povidone-iodine solution in traumatic lacerations prior to suturing reduces the incidence of wound infections.
Povidone-iodine irrigation of the subcutaneous tissue to prevent surgical wound infections. [2017]In a prospective randomized trial, the influence of irrigation of the subcutaneous tissue using povidone-iodine solution upon the development of postoperative wound infection was examined in 592 patients undergoing general surgical operative procedures. No beneficial effect of irrigation with povidone-iodine solution could be demonstrated, nor could it be demonstrated in the group as a whole or in the subgroups according to bacterial contamination.
Ineffectiveness of povidone-iodine irrigation of abdominal incisions. [2017]Two to four percent of uncontaminated surgical wounds become infected; the incidence is increased in contaminated cases. The present study was designed to determine the efficacy of wound irrigation with povidone-iodine in patients not receiving prophylactic antibiotics who were undergoing gynecologic operations. The results revealed no significant difference in the relatively high occurrence of wound infections, morbidity, and elevated fever indices between the povidone-iodine wound irrigation group of patients and the control group. From a review of previous studies of topical antibiotics and antiseptics in contaminated cases as well as from the present findings, providone-iodine wound irrigation without assocaited use of prophylactic antibiotics does not appear to reduce significantly the incidence of wound infections in patients with potential vaginal contamination.
Povidone-iodine induced post-surgical irritant contact dermatitis localized outside of the surgical incision area. Report of 27 cases and a literature review. [2017]Povidone-iodine solution is an antiseptic that is used worldwide as surgical paint and is considered to have a low irritant potential. Post-surgical severe irritant dermatitis has been described after the misuse of this antiseptic in the surgical setting.
Aqueous Povidone-Iodine Versus Normal Saline For Intraoperative Wound Irrigation on The Incidence of Surgical Site Infection in Clean-Contaminated Wounds After Gastroenterological Surgery: A Single-Institute, Prospective, Blinded-Endpoint, Randomized Controlled Trial. [2023]This trial evaluated the superiority of intraoperative wound irrigation (IOWI) with aqueous povidone-iodine (PVP-I) compared with that with saline for reducing the incidence of surgical site infection (SSI).
Prevention of Surgical Site Infection Following Open Spine Surgery: The Efficacy of Intraoperative Wound Irrigation with Normal Saline Containing Gentamicin Versus Dilute Povidone-Iodine. [2023]Intraoperative wound irrigation (IOWI) is an important step in preventing surgical site infection (SSI). This study compared the effectiveness of saline with gentamicin versus povidine-iodine (PI) as IOWI solutions in preventing SSI in open spine surgery.
A Review of Surgical Irrigation Solutions for Infection Prevention in Orthopaedic Surgery. [2023]» Intraoperative surgical irrigation is a common practice in orthopaedic procedures, although there is no universally established standard of care due to a lack of concrete data supporting an optimal irrigation agent.» Isotonic normal saline has long been considered a safe and cost effective solution for wound irrigation as compared with other antibiotic and antiseptic irrigation solutions.» Currently, the only adjunct to saline that is formally supported by American Academy of Orthopaedic Surgeons, the Centers for Disease Control and Prevention, and World Health Organization is povidone-iodine.» Further in vivo clinical studies are needed to identify the ideal irrigation solution that carries low cytotoxic effects while also exerting optimal antimicrobial properties.