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

This study has been terminated.

(terminated, due to lack enrollment,)

Sponsor:

Information provided by:

The University of Texas Health Science Center at San Antonio

ClinicalTrials.gov Identifier:

NCT00121537

First received: July 13, 2005

Last updated: February 9, 2010

Last verified: February 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

July 13, 2005

Last Updated Date

February 9, 2010

Start Date ^ICMJE

July 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Rate of wound healing

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00121537 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Time to delayed primary wound closure
Time to completion of secondary healing
Patient satisfaction
Nurse satisfaction

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Prospective Study to Determine the Utility of Vacuum Assisted Closure (VAC) Compared to Conventional Saline Dressing Changes With Regards to Lower Extremity Fasciotomy Wound Healing, Complications, Cost and Patient and Nursing Satisfaction

Brief Summary

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Wounds
Compartment Syndromes

Intervention ^ICMJE

Device: Wound Care -Wound Vacuum Assisted Closure (VAC)
Procedure: Wound Care - Wet to Dry Dressing Changes

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

October 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00121537

Other Study ID Numbers ^ICMJE

045-1502-226

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

The University of Texas Health Science Center at San Antonio

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

John G Myers, MD

University of Texas Health Science Center at San Antonio

Information Provided By

The University of Texas Health Science Center at San Antonio

Verification Date

February 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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