Surgiphor Solution for Preventing Infections After Joint Surgery

Recruiting at 3 trial locations

Overseen By Tiffany Morrison, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Center for Innovation and Research Organization

Disqualifiers: Iodine allergy, Life expectancy <1 year, others

Compensation: Varies

Number of Visits: Unknown

Duration: During surgery

868 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a special cleaning solution called PVP-I (Surgiphor) to see if it can lower the risk of infections after hip and knee replacement surgeries. The solution is used to disinfect the surgical area, killing harmful germs. The study focuses on patients who are having these surgeries redone because they are at higher risk for infections.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

What data supports the effectiveness of the treatment Surgiphor Solution for preventing infections after joint surgery?

Research suggests that using antiseptic irrigation solutions, like Surgiphor, can help reduce the risk of surgical site infections. A study found that antiseptic irrigation solutions were effective in lowering infection rates compared to non-antibacterial solutions. ^{1 2 3 4 5}

How is Surgiphor Irrigation Solution different from other treatments for preventing infections after joint surgery?

Surgiphor Irrigation Solution is unique because it is specifically designed to prevent infections by being used as an irrigation solution during joint surgery, which is different from traditional methods like topical gels or skin preparations. This approach targets the surgical site directly, potentially offering a more direct method of reducing infection risk compared to other treatments that focus on skin preparation or post-operative care. ^{2 3 4 6 7}

Eligibility Criteria

This trial is for adults over 18 who need a total hip or knee revision surgery and can give informed consent. It's not for those with iodine allergies, life expectancy less than one year, or women who are pregnant or breastfeeding.

Inclusion Criteria

I understand the study, its risks, and agree to participate by signing the consent form.

I am scheduled for a knee or hip revision surgery due to non-infectious reasons.

I am a man, or I am a woman who is not pregnant, not breastfeeding, and cannot have children.

Exclusion Criteria

Subjects with a life expectancy less than one year, in the opinion of the Investigator, which is the follow-up period of the study

Subjects unwilling to sign informed consent

Subjects with known allergies to iodine or any other ingredients in Surgiphor

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Surgiphor or sterile saline irrigation solution during revision arthroplasty

During surgery

Follow-up

Participants are monitored for acute prosthetic joint infection and other complications

1 year

Treatment Details

Interventions

• Sterile Saline
• Surgiphor Irrigation Solution

Trial Overview The study compares Surgiphor irrigation solution to sterile saline in preventing joint infections after hip or knee replacement surgeries. Participants will be randomly assigned to receive either Surgiphor or saline during their procedure.

Participant Groups

Group I: Surgiphor: sterile povidone iodine irrigation solution Active Control 1 Intervention

Surgiphor Wound Irrigation Solution, bottle consisting of sterile 0.5% PVP-I formulation with 0.9% saline, Potassium Iodide, Phosphate Buffer, Vitamin E TPGS

Group II: Sterile saline Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Center for Innovation and Research Organization

Lead Sponsor

Trials

7

Recruited

1,800+

Findings from Research

Current research on antiseptic irrigation solutions for preventing and treating periprosthetic joint infections is limited, with a significant lack of prospective studies.

Low-pressure povidone-iodine is the most strongly supported antiseptic for preventing periprosthetic joint infections, while using multiple solutions in sequence may enhance treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiseptic Irrigation Solutions Used in Total Joint Arthroplasty: A Critical Analysis Review. Christopher, ZK., Deckey, DG., Pollock, JR., et al.[2023]

References

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

Intra-Cavity Lavage and Wound Irrigation for Prevention of Surgical Site Infection: Systematic Review and Network Meta-Analysis. [2021]

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

Antiseptic Irrigation Solutions Used in Total Joint Arthroplasty: A Critical Analysis Review. [2023]

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

Retrospective evaluation of an iodophor-incorporated antimicrobial plastic adhesive wound drape. [2013]

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

Irrigation Solutions and Antibiotic Powders: Should I Use Them in Primary and Revision Total Joint Arthroplasty? [2022]

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

Bundled-Care Program for the Prevention of Surgical-Site Infections Following Lower Extremity Total Joint Arthroplasty. [2021]

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

Comparison of a one-step iodophor skin preparation versus traditional preparation in total joint surgery. [2013]

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

Superficial Surgical Site Infections in Primary Total Joint Arthroplasty: A Retrospective Analysis of Topical Anti-Biofilm Therapy. [2023]