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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:
ClinicalTrials.gov Identifier:
NCT00121537
First Posted: July 21, 2005
Last Update Posted: October 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The University of Texas Health Science Center at San Antonio
  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: None (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

Resource links provided by NLM:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 The University of Texas Health Science Center at San Antonio
  More Information

ClinicalTrials.gov Identifier: NCT00121537     History of Changes
Other Study ID Numbers: 045-1502-226
First Submitted: July 13, 2005
First Posted: July 21, 2005
Last Update Posted: October 8, 2015
Last Verified: October 2015

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

Additional relevant MeSH terms:
Wounds and Injuries
Compartment Syndromes
Muscular Diseases
Musculoskeletal Diseases
Vascular Diseases
Cardiovascular Diseases