Wound Irrigation for Surgical Site Infection

Not currently recruiting at 14 trial locations

Overseen By Rachel Roke, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Povidone-iodine allergy, Active infection, Dirty incision

Compensation: Varies

Number of Visits: 1

Duration: Surgery day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether washing a surgical incision with an antiseptic (a germ-killing solution) or salt water can reduce infections after surgery. It focuses on surgeries involving the abdomen or groin. Participants should be adults planning to have either open or laparoscopic surgery in these areas. The goal is to determine if this simple step can prevent infections within 30 days after surgery, potentially benefiting patients and the healthcare system. As an unphased trial, this study allows participants to contribute to important research that could improve surgical outcomes for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Past research has shown that using a povidone-iodine solution to wash wounds during surgery kills many germs, including strong ones like MRSA (a type of bacteria). However, studies have shown mixed results on its effectiveness in preventing infections after surgery. Some research suggests it might not significantly reduce the risk of surgical site infections (SSIs).

Saline, or saltwater, is generally considered safe and is often used in medical settings to clean wounds. It is gentle and usually well-tolerated, meaning it rarely causes problems for patients.

Overall, both povidone-iodine and saline solutions have been used in surgeries and are considered safe based on past studies. However, their effectiveness in reducing SSIs continues to be studied. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these wound irrigation methods because they offer different approaches to preventing surgical site infections. Povidone-iodine solution is an antiseptic known for its powerful germ-killing ability, potentially reducing infection risk more effectively than traditional methods. On the other hand, using saline as a placebo comparator allows researchers to evaluate the effectiveness of irrigation itself, compared to standard incision management with no irrigation. By comparing these options, researchers hope to determine the best method for reducing infections, ultimately leading to improved surgical outcomes.

What evidence suggests that this trial's treatments could be effective for reducing surgical site infections?

This trial will compare different methods of wound irrigation to prevent surgical site infections (SSIs). Participants in one arm will receive intraoperative incisional wound irrigation with povidone-iodine solution. Research has shown that this solution might help reduce SSIs, especially in surgeries like those on the spine, though other studies suggest it doesn't always offer additional protection against infections. Another arm will use saline solution, a basic cleaning method without specific infection-fighting properties. The evidence remains mixed, so the trial aims to clarify the effectiveness of these solutions in preventing SSIs. ^{1 2 3 5 6}

Who Is on the Research Team?

Paul Karanicolas, MD, PhD

Principal Investigator

Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

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.

You are a registered holder of the Ontario Health Insurance Plan.

Exclusion Criteria

You have a known allergy to povidone-iodine irrigation.

I do not have any active infections.

Known or anticipated CDC Class IV (Dirty) incision

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo elective surgery with randomization to incisional wound irrigation with povidone-iodine, saline, or no irrigation

Surgery day

1 visit (in-person)

Follow-up

Participants are monitored for the incidence of surgical site infections and other outcomes

30 days

Regular follow-up visits (in-person and/or virtual)

Extended Follow-up

Additional outcomes such as healthcare utilization and postoperative complications are collected

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Intraoperative incisional wound irrigation with povidone-iodine solution
• Intraoperative incisional wound irrigation with saline

Trial Overview 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.

How Is the Trial Designed?

Group I: Povidone-iodine solution Experimental Treatment 1 Intervention

Group II: No irrigation Active Control 1 Intervention

Standard incision management

Group III: Saline Placebo Group 1 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

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Published Research Related to This Trial

In a study involving 941 patients undergoing gastroenterological surgery, intraoperative wound irrigation (IOWI) with aqueous povidone-iodine (PVP-I) did not significantly reduce the incidence of surgical site infections (SSI) compared to saline, with SSI rates of 7.6% for PVP-I and 5.1% for saline.

The results suggest that the current recommendation for using IOWI with PVP-I for preventing SSIs may need to be reevaluated, as the difference in infection rates was not statistically significant (P = 0.154).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Maemoto, R., Noda, H., Ichida, K., et al.[2023]

In a study of patients undergoing gynecologic operations without prophylactic antibiotics, wound irrigation with povidone-iodine did not significantly reduce the incidence of wound infections compared to a control group.

The findings suggest that povidone-iodine irrigation alone is ineffective in preventing infections in contaminated surgical wounds, indicating that additional preventive measures may be necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ineffectiveness of povidone-iodine irrigation of abdominal incisions. Galle, PC., Homesley, HD.[2017]

Povidone-iodine, while generally considered a low irritant antiseptic, can cause severe contact dermatitis when used improperly, particularly in areas where it pools or is occluded during surgery, as observed in 27 patients evaluated between 2011 and 2013.

The dermatitis typically appeared the day after surgery, and patch testing showed no allergic reaction to povidone-iodine, suggesting that the irritation was due to prolonged skin contact rather than an allergic response, highlighting the need for better drying practices to prevent this complication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Povidone-iodine induced post-surgical irritant contact dermatitis localized outside of the surgical incision area. Report of 27 cases and a literature review. Borrego, L., Hernández, N., Hernández, Z., et al.[2017]

In a study of 500 surgical patients, using povidone-iodine solution to irrigate incisions before closure significantly reduced the rate of wound infections compared to saline irrigation.

The incidence of wound sepsis was only 2.9% in the povidone-iodine group, compared to 15.1% in the saline group, highlighting the efficacy of povidone-iodine in preventing infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Irrigation of subcutaneous tissue with povidone-iodine solution for prevention of surgical wound infections. Sindelar, WF., Mason, GR.[2017]

In a study involving 592 patients undergoing general surgery, irrigation of subcutaneous tissue with povidone-iodine solution did not reduce the incidence of postoperative wound infections.

The lack of benefit was consistent across the entire patient group and various subgroups, regardless of the level of bacterial contamination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Povidone-iodine irrigation of the subcutaneous tissue to prevent surgical wound infections. de Jong, TE., Vierhout, RJ., van Vroonhoven, TJ.[2017]

In a study of 500 emergency department patients with traumatic lacerations, using a topical 1% povidone-iodine solution before suturing significantly reduced the infection rate compared to wounds treated with normal saline alone.

Only 5.4% of wounds treated with povidone-iodine became infected, compared to 15.46% of control wounds, indicating that povidone-iodine is an effective antiseptic for preventing infections in traumatic lacerations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A trial of povidone-iodine in the prevention of infection in sutured lacerations. Gravett, A., Sterner, S., Clinton, JE., et al.[2019]

In a study of 80 patients undergoing noninstrumented open spine surgery, using 3.5% dilute povidine-iodine (PI) for intraoperative wound irrigation significantly reduced the surgical site infection (SSI) rate to 2.5%, compared to 17.5% with saline containing gentamicin, indicating superior efficacy of PI in preventing infections.

The study found that in the lumbosacral region, the SSI rate was particularly high at 31.6% for the gentamicin group, while the PI group had a 0% infection rate, highlighting the importance of the irrigation solution in this specific surgical area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of Surgical Site Infection Following Open Spine Surgery: The Efficacy of Intraoperative Wound Irrigation with Normal Saline Containing Gentamicin Versus Dilute Povidone-Iodine. Inojie, MO., Okwunodulu, O., Ndubuisi, CA., et al.[2023]

Isotonic normal saline is widely used for surgical irrigation in orthopaedic procedures due to its safety and cost-effectiveness, but there is no universally accepted standard for the best irrigation agent.

Current guidelines support the use of povidone-iodine as an adjunct to saline, highlighting the need for further clinical studies to determine the most effective irrigation solution that minimizes cytotoxicity while maximizing antimicrobial effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Surgical Irrigation Solutions for Infection Prevention in Orthopaedic Surgery. Chambers, MM., Namdari, S.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38825398/

Effects of povidone-iodine wound irrigation on surgical site ... Povidone-iodine wound irrigation has shown no additional beneficial effect on the occurrence of surgical site infections.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0039606024002861

Effects of povidone-iodine wound irrigation on surgical site ... Povidone-iodine wound irrigation has shown no additional beneficial effect on the occurrence of surgical site infections.

3. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2817941

Incisional Wound Irrigation for the Prevention of Surgical ... Incisional wound irrigation with aqueous antiseptic solutions was associated with a reduction in the risk of SSIs; results suggest that the use of antibiotic ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6728529/

Intraoperative povidone-iodine irrigation for infection ... Our experience suggests that an intraoperative soak of 0.3% povidone-iodine solution for up to 3 minutes (Table 1) is an efficacious and cost-effective tool ...

5. eor.bioscientifica.com eor.bioscientifica.com/view/journals/eor/9/11/EOR-24-0091.xml

Does intraoperative wound irrigation with diluted povidone ... IOWI with PI solution during spinal surgery can effectively reduce the incidence of postoperative SSI. Keywords: intraoperative wound irrigation ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5642872/

Intraoperative Disinfection by Pulse Irrigation with Povidone ... Povidone-iodine is an antiseptic agent with bactericidal activity against most pathogens including methicillin-resistant Staphylococcus aureus (MRSA) [35–38].