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NCT01171534 · ClinicalTrials.gov registry record · NA

Closure of Fasciotomy Wounds: A Prospective, Observational Study of a Continuous External Tissue Expander

A NA study, sponsored by University of Missouri-Columbia.

Terminated
Registry status
NA
Development phase
7
Enrollment target

NCT01171534: Clinical Trial NA study, sponsored by University of Missouri-Columbia.

NCT01171534 is a NA study that was terminated before completion, run by University of Missouri-Columbia. The registered enrollment target is 7 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01171534, a NA study, was terminated before completion, sponsored by University of Missouri-Columbia.

TERMINATED
Registry status
NA
Development phase
7 participants
Enrollment target

Study Summary

Fasciotomy wounds are rarely able to be closed at the time of index surgery. They often require multiple returns to surgery for closure, and occasionally require skin grafting (i.e. they are never completely closed). We are interested in seeing whether this device, which provides constant and gradual tension on the wound, may allow for rapid wound closure in a safe fashion, perhaps even precluding a return trip to surgery. Null hypothesis #1: The Dermaclose Wound Management System (Woundcare Technologies Inc, Chanhassen, Minnesota) will not result in closure of fasciotomy wounds more rapidly than standard vessel loop techniques. Null hypothesis #2: The Dermaclose Wound Management System will not reduce the number of return trips to the operating room for surgical procedures related to closure or skin grafting of fasciotomy wounds.

Primary Outcome

Days to wound closure; number and types of procedures required for wound closure; infection requiring reoperation; wound dehiscence requiring reoperation

Interventions

  • DEVICE DermaClose fasciotomy closure
  • DEVICE Vessel loop

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2010-07
Est. Completion 2014-02
Phase NA
University of Missouri-Columbia

291 total trials

Why NCT01171534 stopped before completion

NCT01171534 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 2 interventions - of which DermaClose fasciotomy closure is the first listed.

NCT01171534 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01171534 about?

NCT01171534 is a clinical study titled "Closure of Fasciotomy Wounds: A Prospective, Observational Study of a Continuous External Tissue Expander". Fasciotomy wounds are rarely able to be closed at the time of index surgery. They often require multiple returns to surgery for closure, and occasionally require skin grafting (i.e. they are never completely closed). We are interested in seeing whether this device, which provides constant and gradua...

What is the current status of trial NCT01171534?

This trial is currently terminated. It is a NA study. The enrollment target is 7 participants. The study started on 2010-07. Estimated completion is 2014-02.

What interventions are being tested in trial NCT01171534?

The interventions under investigation include: DermaClose fasciotomy closure (DEVICE), Vessel loop (DEVICE).

Who is sponsoring clinical trial NCT01171534?

This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01171534's enrollment target sits among peer trials

7 1982nd of 2000 higher than 18 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 NCT01171534, the US trial registry maintained by the National Library of Medicine. NCT01171534 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.