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NCT04075526 · ClinicalTrials.gov registry record · Phase 1
Vancomycin Powder and Dilute Povidone Iodine Lavage for Infection Prophylaxis in High Risk Total Joint Arthroplasty
A Phase 1 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 2,129
- Enrollment target
NCT04075526: Completed Phase 1 study, sponsored by NYU Langone Health.
NCT04075526 is a Phase 1 study that has completed, run by NYU Langone Health. The registered enrollment target is 2,129 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (3448% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04075526, a Phase 1 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 2,129 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The definition of periprosthetic infection exists when the following criteria are met: * NEW MSIS criteria for PJI: 1 major criteria (2) or 6 minor criteria (6) 26-28 * Major Criteria: \[1\] sinus tract \[2\] + Cx from 2 separate aspirations * Minor Criteria: \[1\] ESR \>30 mm/hr (1 point), \[2\] D-dimer \>860 ng/mL or CRP \>1 mg/dL \[2\] increased synovial WBC (\>3000 cells/microliter) \[4\] alpha-defensin (signal-to-cutoff ratio\>1) \[5\] leukocyte esterase (++) \[6\] increased synovial PMNs
Interventions
- OTHER Conventional
- DRUG Povidone iodine
- DRUG Vancomycin powder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,129 participants |
| Start Date | 2019-10-01 |
| Est. Completion | 2025-12-13 |
| Phase | Phase 1 |
What the finished NCT04075526 record still lists
NCT04075526 is an interventional study that assigns participants to a tested intervention. Its 2,129 participants enrollment target places it among the larger protocols in the corpus, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (3448% higher).
The record links to 0 conditions, and to 3 interventions - of which Conventional is the first listed.
NCT04075526 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04075526 about?
NCT04075526 is a clinical study titled "Vancomycin Powder and Dilute Povidone Iodine Lavage for Infection Prophylaxis in High Risk Total Joint Arthroplasty". 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.
What is the current status of trial NCT04075526?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 2,129 participants. The study started on 2019-10-01. Estimated completion is 2025-12-13.
What interventions are being tested in trial NCT04075526?
The interventions under investigation include: Conventional (OTHER), Povidone iodine (DRUG), Vancomycin powder (DRUG).
Who is sponsoring clinical trial NCT04075526?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04075526's enrollment target sits among peer trials
2,129 3rd of 2000 higher than 1,998 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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