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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
  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 October 16, 2012