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NCT05849090 · ClinicalTrials.gov registry record · Early Phase 1
Vancomycin and Tobramycin Powder Use in Acute Open Fractures
A Early Phase 1 study, sponsored by University of Utah.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
NCT05849090: Completed Early Phase 1 study, sponsored by University of Utah.
NCT05849090 is a Early Phase 1 study that has completed, run by University of Utah. The registered enrollment target is 10 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05849090, a Early Phase 1 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
The investigators overall aim of this study is to determine the difference in 6-month infection rates in patients treated with the combined vancomycin and tobramycin (VT) powder compared to the standard of care (SC). In order to evaluate this objective, the investigators propose the following specific aims for the pilot study: Specific Aim 1: Assess VT and SC patient enrollment, randomization and early clinical follow-up. Hypothesis: This study will successfully enroll and randomize 50 patients, 25 into each treatment group and will achieve 85% clinical follow-up at 6-months post-ED admission date. Open fracture patients/families that meet study inclusion/exclusion criteria will be approached by a study team member for informed consent. After providing consent, patients will be appropriately randomized to either VT or SC treatment. Patients will be clinically followed at regular intervals up to 6 months post-surgery. Enrollment, appropriate randomization and surgical allocation, and clinical follow-up will be evaluated. Specific Aim 2: Compare infection rates, cultures and patient characteristics between groups. Hypothesis: VT will have a lower infection rate than the SC group. Additionally, randomization will create an equal distribution of patient demographics as well as fracture severity and soft tissue damage, as classified by the Gustilo-Anderson Classification System (GA). Specific Aim 3: Compare local wound healing and fracture healing between VT group and SC group. Hypothesis: VT will have less rates of wound healing complications due to decreased infections. No local wound irritation or wound closure issues will be seen between groups. There will be no difference in fracture healing between groups.
Primary Outcome
Percent (%) of positive deep tissue infections (number of infections/total participants X 100).
Interventions
- DRUG Cephalosporin or clindamycin/vancomycin antibiotics..
- DRUG Vancomycin and Tobramycin antibiotics.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2023-03-27 |
| Est. Completion | 2024-12-12 |
| Phase | Early Phase 1 |
What the finished NCT05849090 record still lists
NCT05849090 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Cephalosporin or clindamycin/vancomycin antibiotics.. is the first listed.
NCT05849090 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05849090 about?
NCT05849090 is a clinical study titled "Vancomycin and Tobramycin Powder Use in Acute Open Fractures". The investigators overall aim of this study is to determine the difference in 6-month infection rates in patients treated with the combined vancomycin and tobramycin (VT) powder compared to the standard of care (SC). In order to evaluate this objective, the investigators propose the following speci...
What is the current status of trial NCT05849090?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2023-03-27. Estimated completion is 2024-12-12.
What interventions are being tested in trial NCT05849090?
The interventions under investigation include: Cephalosporin or clindamycin/vancomycin antibiotics.. (DRUG), Vancomycin and Tobramycin antibiotics. (DRUG).
Who is sponsoring clinical trial NCT05849090?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05849090's enrollment target sits among peer trials
10 1628th of 2000 higher than 256 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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