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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04580472
The ClinicalTrials.gov registry entry for NCT04580472 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 1,600 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 504-participant average among 25 other Surgical Site Infection trials with a reported enrollment target (217% higher). The listed sponsor is Carilion Clinic, which has 45 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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