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, )

First Received on July 13, 2005. Last Updated on February 9, 2010 History of Changes

Sponsor:	The University of Texas Health Science Center at San Antonio
Information provided by:	The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:	NCT00121537

Purpose

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.

Condition	Intervention
Wounds Compartment Syndromes	Device: Wound Care -Wound Vacuum Assisted Closure (VAC) Procedure: Wound Care - Wet to Dry Dressing Changes

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:

Rate of wound healing

Secondary Outcome Measures:

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

Estimated Enrollment:	30
Study Start Date:	July 2005
Study Completion Date:	October 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121537

Locations

United States, Texas
University Hospital
San Antonio, Texas, United States, 78229-4493

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio

Investigators

Principal Investigator:

John G Myers, MD

University of Texas

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00121537 History of Changes
Other Study ID Numbers:	045-1502-226
Study First Received:	July 13, 2005
Last Updated:	February 9, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center at San Antonio:

wounds-open

Additional relevant MeSH terms:

Compartment Syndromes
Muscular Diseases
Musculoskeletal Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012