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NCT03523962 · ClinicalTrials.gov registry record · Phase 4
Pre-operative Alcohol Skin Solutions in Fractured Extremities
A Phase 4 study, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- Phase 4
- Development phase
- 8,485
- Enrollment target
NCT03523962: Completed Phase 4 study, sponsored by University of Maryland, Baltimore.
NCT03523962 is a Phase 4 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 8,485 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (1538% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03523962, a Phase 4 study, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 8,485 participants
- Enrollment target
Study Summary
The prevention of infection is an important goal influencing peri-operative care of extremity fracture patients. Standard practice in the operative management of extremity fractures includes sterile technique and pre-operative skin preparation with an antiseptic solution. The available solutions kill bacteria and decrease the quantity of native skin flora, thereby decreasing surgical site infection (SSI). While there is extensive guidance on specific procedures for prophylactic antibiotic use and standards for sterile technique, the evidence regarding the choice of antiseptic skin preparation solution is very limited for extremity fracture surgery.
Primary Outcome
Guided by the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network reporting criteria (2017): Date of event for infection may occur from the date of fracture to 30 days after the definitive fracture management surgery; AND involves only skin and subcutaneous tissue of the incision; AND patient has at least one of the following: 1. purulent drainage from the superficial incision. 2. organisms identified from an aseptically obtained specimen from the superficial in
Interventions
- DRUG ChloraPrep
- DRUG DuraPrep
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8,485 participants |
| Start Date | 2018-08-21 |
| Est. Completion | 2024-02-02 |
| Phase | Phase 4 |
What the finished NCT03523962 record still lists
NCT03523962 is an interventional study that assigns participants to a tested intervention. Its 8,485 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (1538% higher).
The record links to 0 conditions, and to 2 interventions - of which ChloraPrep is the first listed.
NCT03523962 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03523962 about?
NCT03523962 is a clinical study titled "Pre-operative Alcohol Skin Solutions in Fractured Extremities". The prevention of infection is an important goal influencing peri-operative care of extremity fracture patients. Standard practice in the operative management of extremity fractures includes sterile technique and pre-operative skin preparation with an antiseptic solution. The available solutions kil...
What is the current status of trial NCT03523962?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 8,485 participants. The study started on 2018-08-21. Estimated completion is 2024-02-02.
What interventions are being tested in trial NCT03523962?
The interventions under investigation include: ChloraPrep (DRUG), DuraPrep (DRUG).
Who is sponsoring clinical trial NCT03523962?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03523962's enrollment target sits among peer trials
8,485 10th of 2000 higher than 1,991 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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