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

Sponsor
The University of Texas Health Science Center at San Antonio (Other)
Overall Status
Terminated
CT.gov ID
NCT00121537
Collaborator
(none)
30
1
15
2

Study Details

Study Description

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

Study Design

Study Type:
Interventional
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 :
Jul 1, 2005
Actual Study Completion Date :
Oct 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00121537
Other Study ID Numbers:
  • 045-1502-226
First Posted:
Jul 21, 2005
Last Update Posted:
Oct 8, 2015
Last Verified:
Oct 1, 2015
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2015