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NCT04580472 · ClinicalTrials.gov registry record · Phase 4
Utility of Single-dose Oral Antibiotic Prophylaxis in Prevention of Surgical Site Infection in Dermatologic Surgery
A Phase 4 study of Surgical Site Infection, sponsored by Carilion Clinic.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 1,600
- Enrollment target
- 1
- Study location
NCT04580472: Recruiting Phase 4 study of Surgical Site Infection, sponsored by Carilion Clinic.
NCT04580472 is a Phase 4 study of Surgical Site Infection that is actively recruiting participants, run by Carilion Clinic. The registered enrollment target is 1,600 participants, above the 504-participant average among 25 other Surgical Site Infection trials with a reported enrollment target (217% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04580472, a Phase 4 study of Surgical Site Infection, is actively recruiting participants, sponsored by Carilion Clinic.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 1,600 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the study is to assess the effectiveness of a single dose of preoperative antibiotic in reducing surgical site infections in certain dermatological procedures. Patients will undergo surgical excision or Mohs surgery as is clinically indicated and part of usual care. The study will be a double blinded, placebo-controlled clinical trial. Patients meeting inclusion criteria will be assigned to one of three participant categories: 1) patients undergoing repair with skin flap or graft on the nose, 2) patients undergoing repair with skin graft, flap, or wedge resection on the ear, or 3) patients undergoing Mohs surgery with closure or partial closure or surgical excision on the lower extremity below the knee. Within each category, participants will be randomized into one of two groups: group one will receive a preoperative placebo pill and group two will receive preoperative antibiotic prophylaxis (either a single dose of Cephalexin 2g PO or single dose of Clindamycin hydrochloride 600 mg PO if allergy to penicillin or cephalosporin). Patients will followed for 30 days +/- 7 after surgery to evaluate for any surgical site infection.
Primary Outcome
Rate of surgical site infection occurrence
Conditions Studied
Interventions
- OTHER Placebo capsules
- DRUG Cephalexin
Study Locations (1)
Virginia
- Carilion Clinic - Roanoke
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,600 participants |
| Start Date | 2020-10-01 |
| Est. Completion | 2026-09 |
| Phase | Phase 4 |
What NCT04580472 shows while recruiting
NCT04580472 is an interventional study that assigns participants to a tested intervention. Its 1,600 participants enrollment target places it among the larger protocols in the corpus, above the 504-participant average among 25 other Surgical Site Infection trials with a reported enrollment target (217% higher).
The record links to 1 condition, with Surgical Site Infection appearing as the primary indexed condition, and to 2 interventions - of which Placebo capsules is the first listed.
NCT04580472 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT04580472 about?
NCT04580472 is a clinical study titled "Utility of Single-dose Oral Antibiotic Prophylaxis in Prevention of Surgical Site Infection in Dermatologic Surgery". The purpose of the study is to assess the effectiveness of a single dose of preoperative antibiotic in reducing surgical site infections in certain dermatological procedures. Patients will undergo surgical excision or Mohs surgery as is clinically indicated and part of usual care. The study will be ...
What is the current status of trial NCT04580472?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 1,600 participants. The study started on 2020-10-01. Estimated completion is 2026-09.
What conditions does trial NCT04580472 study?
This clinical trial studies the following conditions: Surgical Site Infection.
What interventions are being tested in trial NCT04580472?
The interventions under investigation include: Placebo capsules (OTHER), Cephalexin (DRUG).
Who is sponsoring clinical trial NCT04580472?
This trial is sponsored by Carilion Clinic, which has 45 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04580472 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Surgical Site Infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04580472's enrollment target sits among peer trials
1,600 4th of 25 higher than 22 of 25 other Surgical Site Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Surgical Site Infection 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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