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NCT02581904 · ClinicalTrials.gov registry record · Phase 4

A Randomized Clinical Trial Evaluating Negative Pressure Therapy to Decrease Vascular Groin Incision Complications

A Phase 4 study, sponsored by Thomas Jefferson University.

Completed
Registry status
Phase 4
Development phase
140
Enrollment target

NCT02581904: Completed Phase 4 study, sponsored by Thomas Jefferson University.

NCT02581904 is a Phase 4 study that has completed, run by Thomas Jefferson University. The registered enrollment target is 140 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02581904, a Phase 4 study, has completed, sponsored by Thomas Jefferson University.

COMPLETED
Registry status
Phase 4
Development phase
140 participants
Enrollment target

Study Summary

The purpose of this study is to determine if the application of a negative pressure dressing intraoperatively (Prevena; KCI, Inc) to vascular groin incisions decreases the wound complication rate in high risk patients.

Primary Outcome

Composite measure including wound dehiscence (skin or fascia), lymph leak (seroma or fistula), infection (deep or superficial), or hematoma

Interventions

  • DEVICE Prevena Care
  • DEVICE Dry gauze dressing care

Trial Details

FieldValue
Enrollment Target 140 participants
Start Date 2015-01
Est. Completion 2017-04
Phase Phase 4
Thomas Jefferson University

292 total trials

What the finished NCT02581904 record still lists

NCT02581904 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower).

The record links to 0 conditions, and to 2 interventions - of which Prevena Care is the first listed.

NCT02581904 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02581904 about?

NCT02581904 is a clinical study titled "A Randomized Clinical Trial Evaluating Negative Pressure Therapy to Decrease Vascular Groin Incision Complications". The purpose of this study is to determine if the application of a negative pressure dressing intraoperatively (Prevena; KCI, Inc) to vascular groin incisions decreases the wound complication rate in high risk patients.

What is the current status of trial NCT02581904?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 140 participants. The study started on 2015-01. Estimated completion is 2017-04.

What interventions are being tested in trial NCT02581904?

The interventions under investigation include: Prevena Care (DEVICE), Dry gauze dressing care (DEVICE).

Who is sponsoring clinical trial NCT02581904?

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 NCT02581904's enrollment target sits among peer trials

140 581st of 2000 higher than 1,408 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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Source: ClinicalTrials.gov NCT02581904, the US trial registry maintained by the National Library of Medicine. NCT02581904 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.