Surgiphor Solution for Preventing Infections After Joint Surgery

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special solution called Surgiphor to determine its effectiveness in preventing infections after hip or knee replacement surgeries. Researchers compare Surgiphor to regular saline (salt water) to assess whether it better reduces infection risk during the first 90 days post-surgery. It targets individuals needing hip or knee revision surgery for non-infection reasons. Participants must not have allergies to iodine, a key ingredient in Surgiphor. As an unphased trial, this study allows participants to contribute to important research that could enhance surgical outcomes for future patients.

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 prior data suggests that Surgiphor Irrigation Solution is safe for preventing infections after joint surgery?

Research shows that povidone-iodine (PVP-I) solutions, such as Surgiphor, can significantly reduce the risk of infections after surgery. Studies have found that this type of solution effectively cleans wounds during surgery by removing germs and dirt.

Regarding safety, no major risks have been reported with povidone-iodine irrigation. The only noted effect is an increase in iodine levels in the blood post-surgery, which is not considered harmful. The Surgiphor system is designed to be sterile, minimizing any risk of contamination during use.

Overall, research suggests that Surgiphor is safe and well-tolerated for surgeries, such as joint replacements, making it a promising option for preventing infections after these procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Surgiphor is unique because it uses a sterile povidone iodine irrigation solution, which combines 0.5% PVP-I with 0.9% saline, potassium iodide, and a phosphate buffer. Unlike the standard antiseptics used in joint surgeries, such as chlorhexidine or plain saline, Surgiphor includes Vitamin E TPGS, which is known for its antioxidant properties and may aid in wound healing. Researchers are excited about Surgiphor because it potentially offers enhanced infection prevention with its multifaceted formulation, addressing both microbial threats and supporting tissue recovery.

What evidence suggests that Surgiphor Irrigation Solution is effective for preventing infections after joint surgery?

Research has shown that antiseptic solutions like Surgiphor, which participants in this trial may receive, can help reduce infections after surgery. One study found that these solutions prevent infections more effectively than those without antibacterial properties. Surgiphor, a sterile liquid, cleans the surgical area and lowers the risk of infection. Although some studies on povidone-iodine (an important ingredient) suggest it may not always provide extra benefits in certain surgeries, Surgiphor's unique formula might offer better protection. The main goal is to keep the surgical site clean and free from bacteria to reduce infections. Participants in this trial may also receive sterile saline as a comparator to evaluate Surgiphor's effectiveness. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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. bd.com bd.com/en-us/products-and-solutions/products/product-families/bd-surgiphor-sterile-wound-irrigation-system

BD Surgiphor™ Antimicrobial Irrigation System Surgiphor™ Antimicrobial Irrigation System is terminally sterile, minimizing the risk of contamination and aligning with USP <797> standards to ensure a sterile ...

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. withpower.com withpower.com/trial/phase-infections-5-2022-9b87d

Surgiphor Solution for Preventing Infections After Joint ... A study found that antiseptic irrigation solutions were effective in lowering infection rates compared to non-antibacterial solutions.

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

Effects of povidone-iodine wound irrigation on surgical site ... This study examined the irrigation efficacy of povidone-iodine for surgical site infection prevention compared to control in gastroenterological surgery.

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

Intraoperative povidone-iodine irrigation for infection ... The prophylactic addition of sterile povidone-iodine irrigation into the perioperative armamentarium confers a significant reduction in SSI risk, with ...

7. bd.com bd.com/content/dam/bd-assets/na/surgery/documents/instructions-for-use/BD-76004%20Surgiphor%20Antimicrobial%20Irrigation_2.pdf

BD Surgiphor™ Antimicrobial Irrigation System It delivers a dilute PVP-I lavage to mechanically loosen and remove debris and foreign materials, including microorganisms from wounds, during surgery. Here are ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2386220/

The efficacy and risks of using povidone-iodine irrigation to ... No significant risks were associated with the use of povidone-iodine irrigation other than increased postoperative serum iodine. Conclusion. Povidone-iodine ...

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K221504.pdf

K221504 - accessdata.fda.gov BD Surgiphor™ Antimicrobial Irrigation System is an antimicrobial irrigation system containing 0.5% povidone iodine (PVP-I) in phosphate-.