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NCT03773575 · ClinicalTrials.gov registry record · NA

Evaluation of Closed Incision Negative Pressure Dressing (PREVENA) to Prevent Lower Extremity Amputation Wound Complications

A NA study, sponsored by Thomas Jefferson University.

Completed
Registry status
NA
Development phase
272
Enrollment target

NCT03773575: Completed NA study, sponsored by Thomas Jefferson University.

NCT03773575 is a NA study that has completed, run by Thomas Jefferson University. The registered enrollment target is 272 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03773575, a NA study, has completed, sponsored by Thomas Jefferson University.

COMPLETED
Registry status
NA
Development phase
272 participants
Enrollment target

Study Summary

This study is a prospective, multi-center, two-arm, unblinded, and randomized controlled trial with a goal of evaluating the impact of a closed incision negative pressure dressing (PREVENA) on incidence of post-operative wound complications and medical costs in patients undergoing lower extremity amputation.

Primary Outcome

Presence of any of the following post-procedure: * Dehiscence (skin or fascia) * Seroma * Lymph leak * Infection (superficial or deep, using CDC Surgical Site Infection criteria) * Hematoma * Ischemia * Necrosis

Interventions

  • DEVICE PREVENA™ PEEL & PLACE™ Dressing Kit

Trial Details

FieldValue
Enrollment Target 272 participants
Start Date 2019-01-15
Est. Completion 2024-08-15
Phase NA
Thomas Jefferson University

292 total trials

What the finished NCT03773575 record still lists

NCT03773575 is an interventional study that assigns participants to a tested intervention. The registered 272 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower).

The record links to 0 conditions, and to 1 intervention - of which PREVENA™ PEEL & PLACE™ Dressing Kit is the first listed.

NCT03773575 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03773575 about?

NCT03773575 is a clinical study titled "Evaluation of Closed Incision Negative Pressure Dressing (PREVENA) to Prevent Lower Extremity Amputation Wound Complications". This study is a prospective, multi-center, two-arm, unblinded, and randomized controlled trial with a goal of evaluating the impact of a closed incision negative pressure dressing (PREVENA) on incidence of post-operative wound complications and medical costs in patients undergoing lower extremity am...

What is the current status of trial NCT03773575?

This trial is currently completed. It is a NA study. The enrollment target is 272 participants. The study started on 2019-01-15. Estimated completion is 2024-08-15.

What interventions are being tested in trial NCT03773575?

The interventions under investigation include: PREVENA™ PEEL & PLACE™ Dressing Kit (DEVICE).

Who is sponsoring clinical trial NCT03773575?

This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03773575's enrollment target sits among peer trials

272 387th of 2000 higher than 1,614 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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 NCT03773575, the US trial registry maintained by the National Library of Medicine. NCT03773575 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.