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NCT03578965 · ClinicalTrials.gov registry record · Phase 2

Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions

A Phase 2 study, sponsored by Washington University School of Medicine.

Completed
Registry status
Phase 2
Development phase
50
Enrollment target

NCT03578965: Completed Phase 2 study, sponsored by Washington University School of Medicine.

NCT03578965 is a Phase 2 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03578965, a Phase 2 study, has completed, sponsored by Washington University School of Medicine.

COMPLETED
Registry status
Phase 2
Development phase
50 participants
Enrollment target

Study Summary

A randomized control trial will provide the most reliable data to determine the role of prophylactic antibiotics to decrease the wound complication rate. The investigators plan to perform a pilot study to evaluate actual rates of wound complications and how long it takes to recruit 50 patients.

Primary Outcome

Wound complication will be defined as a composite outcome that includes wound breakdown, sterile site infection, hematoma, seroma diagnosed within 30 days after excision. Sterile Site Infection (SSI) - defined as purulent drainage, cellulitis, abscess, or a wound that requires drainage, debridement or antibiotics associated with a clinical diagnosis of infection.

Interventions

  • DRUG Cefazolin

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2018-07-13
Est. Completion 2021-11-23
Phase Phase 2

What the finished NCT03578965 record still lists

NCT03578965 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).

The record links to 0 conditions, and to 1 intervention - of which Cefazolin is the first listed.

NCT03578965 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03578965 about?

NCT03578965 is a clinical study titled "Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions". A randomized control trial will provide the most reliable data to determine the role of prophylactic antibiotics to decrease the wound complication rate. The investigators plan to perform a pilot study to evaluate actual rates of wound complications and how long it takes to recruit 50 patients.

What is the current status of trial NCT03578965?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2018-07-13. Estimated completion is 2021-11-23.

What interventions are being tested in trial NCT03578965?

The interventions under investigation include: Cefazolin (DRUG).

Who is sponsoring clinical trial NCT03578965?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03578965's enrollment target sits among peer trials

50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT03578965, the US trial registry maintained by the National Library of Medicine. NCT03578965 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.