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NCT07561541 · ClinicalTrials.gov registry record · Phase 4
Extended Oral Antibiotic Prophylaxis in Diabetic Fracture Patients
A Phase 4 study, sponsored by Texas Tech University Health Sciences Center, El Paso.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
NCT07561541: Recruiting Phase 4 study, sponsored by Texas Tech University Health Sciences Center, El Paso.
NCT07561541 is a Phase 4 study that is actively recruiting participants, run by Texas Tech University Health Sciences Center, El Paso. The registered enrollment target is 40 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07561541, a Phase 4 study, is actively recruiting participants, sponsored by Texas Tech University Health Sciences Center, El Paso.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to learn if taking an antibiotic pill for 7 days after surgery reduces the risk of wound infection in adults with poorly controlled diabetes who have surgery to fix a broken bone in the leg, ankle, or foot. It will also learn about the safety of the extended antibiotic course. The main questions it aims to answer are: Does a 7-day antibiotic course after surgery lower the rate of wound infection within 90 days? What medical problems do participants have when taking the extended antibiotic course? Researchers will compare a 7-day course of an oral antibiotic (cefadroxil) to standard care (no additional antibiotics after surgery) to see if the extended course reduces infections. Participants will: Take an antibiotic pill or receive standard care for 7 days after surgery Receive a phone call from the study team about 1 week after surgery Visit the clinic at 3 weeks, 6 weeks, and 3 months after surgery for checkups
Primary Outcome
Incidence of superficial infection (a wound with erythema, warmth, or drainage that is treated with oral antibiotics or wound care) and deep infection (per fracture-related infection definition).
Interventions
- DRUG Clindamycin
- DRUG Cefadroxil 500 mg Capsules
- DRUG Bactrim DS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2026-04-01 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 4 |
What NCT07561541 shows while recruiting
NCT07561541 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Clindamycin is the first listed.
NCT07561541 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07561541 about?
NCT07561541 is a clinical study titled "Extended Oral Antibiotic Prophylaxis in Diabetic Fracture Patients". The goal of this clinical trial is to learn if taking an antibiotic pill for 7 days after surgery reduces the risk of wound infection in adults with poorly controlled diabetes who have surgery to fix a broken bone in the leg, ankle, or foot. It will also learn about the safety of the extended antibi...
What is the current status of trial NCT07561541?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2026-04-01. Estimated completion is 2027-12-31.
What interventions are being tested in trial NCT07561541?
The interventions under investigation include: Clindamycin (DRUG), Cefadroxil 500 mg Capsules (DRUG), Bactrim DS (DRUG).
Who is sponsoring clinical trial NCT07561541?
This trial is sponsored by Texas Tech University Health Sciences Center, El Paso, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07561541's enrollment target sits among peer trials
40 1397th of 2000 higher than 533 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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