Infection Prophylaxis with Vancomycin + Povidone Iodine for Post-Surgical Joint Infections

Recruiting at 13 trial locations

Overseen By Ran Schwarzkopf, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: NYU Langone Health

Disqualifiers: Pregnancy, Psychiatric disorder, Severe dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Surgery day

2129 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment with Vancomycin and Povidone Iodine for preventing post-surgical joint infections?

Research shows that using povidone-iodine can effectively reduce infections in joint surgeries, and vancomycin powder has been successful in preventing infections in spine surgeries. Combining these two treatments may help lower the risk of infections after joint surgeries. ^{1 2 3 4 5}

Is the combination of vancomycin powder and povidone-iodine safe for preventing infections after surgery?

Research suggests that using vancomycin powder and povidone-iodine together is generally safe for preventing infections after joint surgeries. These treatments have been used in surgeries like joint replacements and spine surgeries without major safety concerns. ^{1 2 6 7 8}

How does the treatment of Vancomycin + Povidone Iodine differ from other treatments for post-surgical joint infections?

This treatment is unique because it combines vancomycin powder, which is effective in preventing infections in surgeries like spine surgery, with povidone-iodine, a common antiseptic that reduces infection rates. This combination aims to decrease the rate of joint infections after surgery by using both an antibiotic and an antiseptic together. ^{1 2 3 8 9}

What is the purpose of this trial?

This is a prospective, randomized, controlled, open label, parallel four-arm design, multi-center study to compare different intraoperative interventions in the prevention of acute PJI development.

Research Team

Ran Schwarzkopf, MD

Principal Investigator

NYU Langone

Eligibility Criteria

This trial is for adults at high risk of infection after joint replacement surgery due to factors like obesity, smoking, weak immune system (from conditions like HIV or treatments like chemotherapy), diabetes, known S. aureus colonization, or needing a revision of their joint surgery. They must understand the procedure and follow the study plan without any active infections in the leg/joint or severe mental incapacity.

Inclusion Criteria

Patient understand the risks and benefits associated with TJA and willing to cooperate and follow study protocol and visit schedule

I do not have an infection in the leg or joint that will be operated on.

I have no open wounds on my leg that needs surgery.

Exclusion Criteria

I don't have any planned procedures within 3 months after surgery.

I am able to understand and follow the study's requirements.

I have an active infection in my leg or joint where surgery is planned.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intraoperative interventions with povidone iodine and/or vancomycin powder during total joint arthroplasty

Surgery day

1 visit (in-person)

Follow-up

Participants are monitored for the rate of periprosthetic joint infection (PJI) after surgery

12 weeks

Regular follow-up visits

Treatment Details

Interventions

• Conventional
• Povidone iodine
• Vancomycin powder

Trial Overview The study tests if applying Vancomycin powder or dilute Povidone Iodine during surgery can prevent acute infections post-joint replacement. It's a controlled comparison with four groups: one standard care and three different interventions, assigned randomly to participants across multiple centers.

Participant Groups

Group I: Povidone iodine and vancomycin powder Experimental Treatment 2 Interventions

Group II: Povidone iodine alone Experimental Treatment 1 Intervention

Group III: Conventional Active Control 1 Intervention

neither povidone iodine, vancomycin powder, nor polymyxin/bacitracin irrigation

Group IV: Vancomycin powder alone Active Control 1 Intervention

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

References

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

The Effect of Povidone-Iodine Irrigation on the Efficacy of Antibiotic Cement In Vitro. [2023]

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

Vancomycin Powder and Dilute Povidone-Iodine Lavage for Infection Prophylaxis in High-Risk Total Joint Arthroplasty. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Effect of povidone-iodine irrigation on the preoperative chemical preparation of the eye. [2017]

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

Clinical outcome evaluation of intraosseous vancomycin in total knee arthroplasty. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of 0.66% Povidone-Iodine Eye Drops on Ocular Surface Flora before Cataract Surgery: A Nationwide Microbiological Study. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Cefazolin remains the linchpin for preventing acute periprosthetic joint infection following primary total knee arthroplasty. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Comparing the efficacy of chlorhexidine and povidone-iodine in preventing surgical site infections: A systematic review and meta-analysis. [2023]

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

Does the Organism Profile of Periprosthetic Joint Infections Change With a Topical Vancomycin Powder and Dilute Povidone-Iodine Lavage Protocol? [2022]

9. Denmark pubmed.ncbi.nlm.nih.gov

Preoperative ocular disinfection by the use of povidone-iodine 5%. [2019]