Study to Determine the Utility of Wound Vacuum Assisted Closure (VAC) Compared to Conventional Saline Dressing Changes

NCT ID: NCT00121537

Last Updated: 2015-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-10-31

Brief Summary

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The purpose of this study is to look at the use of the wound vacuum assisted closure (VAC) versus standard wet to dry dressing in treating lower leg fasciotomies.

Detailed Description

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Conditions

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Wounds Compartment Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Wound Care -Wound Vacuum Assisted Closure (VAC)

Intervention Type DEVICE

Wound Care - Wet to Dry Dressing Changes

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* four compartment fasciotomies performed on one or both lower extremities
* subject and/or subject's legally authorized representative (next-of-kin) has voluntarily signed and dated informed consent.

Exclusion Criteria

* inability to place wound VAC
* contraindications for wound VAC use
* pregnant females
* prisoners
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Principal Investigators

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John G Myers, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

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University Hospital

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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045-1502-226

Identifier Type: -

Identifier Source: org_study_id

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