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

Not currently recruiting at 13 trial locations
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Ran Schwarzkopf, MD profile photo
Overseen ByRan Schwarzkopf, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to prevent infections after joint replacement surgeries. Researchers are testing different combinations of vancomycin (an antibiotic) and povidone iodine (an antiseptic) to determine which best stops infections from developing. Participants will receive one of four treatments: both vancomycin and povidone iodine, just vancomycin, just povidone iodine, or neither. This trial may suit those scheduled for a joint replacement due to conditions like osteoarthritis or inflammatory arthritis, especially if they have factors such as a BMI over 35, smoking habits, or diabetes. As a Phase 1 trial, the research focuses on understanding how the treatment works in people.

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.

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

Research has shown that a mix of vancomycin powder and povidone iodine is safe for patients. Studies indicate that this combination can reduce the risk of infections after surgery. Specifically, one study found that this mix is well-tolerated and may help lower complications in high-risk patients.

Vancomycin powder alone also shows promise. Reviews highlight its ability to reduce infection rates after surgeries without major safety issues.

Povidone iodine alone is a reliable antiseptic, effectively killing bacteria without slowing wound healing. Studies show it works well and is safe to use at different stages of surgery.

Overall, these treatments have strong safety records based on available research.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores the potential of using vancomycin and povidone iodine to prevent post-surgical joint infections. Unlike conventional treatments that may not specifically target the bacteria responsible for these infections, vancomycin is an antibiotic that targets Gram-positive bacteria, which are common culprits in joint infections. Povidone iodine adds another layer of defense with its broad-spectrum antiseptic properties. By combining these two agents, the trial aims to enhance infection prevention more effectively than traditional methods alone. This approach could lead to fewer complications and faster recovery times for patients undergoing joint surgeries.

What evidence suggests that this trial's treatments could be effective for preventing post-surgical joint infections?

Research has shown that vancomycin powder, one of the treatments in this trial, can significantly reduce infection rates after surgeries, lowering the risk by more than half. Povidone iodine, another treatment option in this trial, effectively prevents infections and performs as well as other antiseptics. This trial will test the combination of povidone iodine and vancomycin powder, which might offer strong protection against post-surgical infections. However, some studies suggest that adding vancomycin powder to povidone iodine does not always provide extra benefits compared to using povidone iodine alone. Overall, evidence supports both treatments in reducing surgery-related infections.678910

Who Is on the Research Team?

Ran Schwarzkopf, MD | NYU Langone Health

Ran Schwarzkopf, MD

Principal Investigator

NYU Langone

Are You a Good Fit for This Trial?

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.
See 2 more

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.
See 7 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Active Control
Group I: Povidone iodine and vancomycin powderExperimental Treatment2 Interventions
Group II: Povidone iodine aloneExperimental Treatment1 Intervention
Group III: ConventionalActive Control1 Intervention
Group IV: Vancomycin powder aloneActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Citations

How effective is diluted povidone-iodine in preventing ...The main outcome from this systematic review and meta-analysis reveals that diluted PI is superior to NS, but similar to antiseptic agents, ...
How effective is diluted povidone-iodine in preventing ...Conclusion. PI irrigation seems an efficient preventive measure for post-operative PJI and would seem to be the most feasible for TJA protocol.
Chlorhexidine or Povidone-Iodine Solution Irrigation ...In this meta-analysis, chlorhexidine and povidone-iodine had a significantly reduced risk of PJI as compared with saline irrigation in total joint arthroplasty.
Povidone Iodine vs Chlorhexidine Gluconate in Alcohol for ...Povidone iodine was noninferior compared with chlorhexidine gluconate as preoperative skin antisepsis in preventing surgical site infections after cardiac or ...
a protocol for multicenter prospective randomized clinical trialPovidone-iodine irrigation reduces infection after total hip and knee arthroplasty. Arch Orthop Trauma Surg. 2023; 10.1007/s00402-022-04451 ...
Non-inferiority and Safety of Increased Povidone-Iodine ...This study demonstrated no difference in rates of all-cause revision or PJI when using 0.3% Betadine versus 0.54% Betadine for irrigation following pTJA.
7.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38435161/
Non-inferiority and Safety of Increased Povidone-Iodine ...Conclusion This study demonstrated no difference in rates of all-cause revision or PJI when using 0.3% Betadine versus 0.54% Betadine for ...
Povidone iodine in wound healing: A review of current ...Povidone iodine is an effective antiseptic that does not impede wound healing. Povidone iodine is bactericidal against Gram-positive and -negative organisms.
Comparison of the effect of combined usage of povidone ...The study will aim to compare the effect of combined usage of povidone-iodine and topical vancomycin powder to the use of povidone-iodine alone on the PJI ...
Evaluation of the role of povidone‑iodine in the prevention ...Scientific evidence demonstrates that PVP-I can be used at every stage of surgical intervention: preoperative, intraoperative, and postoperative.
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