Wound Irrigation for Surgical Site Infection

Recruiting at 13 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

2500 Participants Needed

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.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Intraoperative incisional wound irrigation with povidone-iodine solution for preventing surgical site infections?

Research shows that using povidone-iodine solution for wound irrigation during surgery significantly reduces wound infections compared to using saline, with a lower infection rate of 2.9% versus 15.1% in one study. ^{1 2 3 4 5}

Is wound irrigation with povidone-iodine or saline safe for humans?

Wound irrigation with povidone-iodine and saline is generally considered safe for humans, though povidone-iodine can sometimes cause skin irritation if misused. Saline is widely regarded as a safe and cost-effective option for wound irrigation. ^{1 3 4 6 7}

How does intraoperative wound irrigation with povidone-iodine or saline differ from other treatments for surgical site infections?

Intraoperative wound irrigation with povidone-iodine is unique because it significantly reduces the incidence of surgical site infections compared to saline irrigation, especially in clean-contaminated wounds, by using an antiseptic solution that kills bacteria. This method is particularly effective in reducing infections in various types of surgical incisions, unlike some other treatments that may not show significant benefits without additional antibiotics. ^{1 3 4 5 8}

Research Team

Paul Karanicolas, MD, PhD

Principal Investigator

Sunnybrook Health Sciences Centre

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.

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Irrigation of subcutaneous tissue with povidone-iodine solution for prevention of surgical wound infections. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Povidone-iodine irrigation of the subcutaneous tissue to prevent surgical wound infections. [2017]

3. United States 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. [2023]

4. United States 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Ineffectiveness of povidone-iodine irrigation of abdominal incisions. [2017]

6. England 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. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

A Review of Surgical Irrigation Solutions for Infection Prevention in Orthopaedic Surgery. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

A trial of povidone-iodine in the prevention of infection in sutured lacerations. [2019]