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

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.
 
ClinicalTrials.gov Identifier: NCT00121537
Recruitment Status : Terminated (terminated, due to lack enrollment,)
First Posted : July 21, 2005
Last Update Posted : October 8, 2015
Sponsor:
Information provided by:
The University of Texas Health Science Center at San Antonio

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.

Condition or disease Intervention/treatment Phase
Wounds Compartment Syndromes Device: Wound Care -Wound Vacuum Assisted Closure (VAC) Procedure: Wound Care - Wet to Dry Dressing Changes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
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
Study Start Date : July 2005
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Rate of wound healing

Secondary Outcome Measures :
  1. Time to delayed primary wound closure
  2. Time to completion of secondary healing
  3. Patient satisfaction
  4. Nurse satisfaction


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
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

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
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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
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Principal Investigator: John G Myers, MD The University of Texas Health Science Center at San Antonio
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ClinicalTrials.gov Identifier: NCT00121537    
Other Study ID Numbers: 045-1502-226
First Posted: July 21, 2005    Key Record Dates
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:
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Compartment Syndromes
Wounds and Injuries
Muscular Diseases
Musculoskeletal Diseases
Vascular Diseases
Cardiovascular Diseases