Back to resultsStudy to Determine the Utility of Wound Vacuum Assisted Closure (VAC) Compared to Conventional Saline Dressing Changes
Primary Purpose
Wounds, Compartment Syndromes
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wound Care -Wound Vacuum Assisted Closure (VAC)
Wound Care - Wet to Dry Dressing Changes
Sponsored by
About this trial
This is an interventional treatment trial for Wounds focused on measuring wounds-open
Eligibility 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
Sites / Locations
- University Hospital
Outcomes
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
Full Information
NCT ID
NCT00121537
First Posted
July 13, 2005
Last Updated
October 7, 2015
Sponsor
The University of Texas Health Science Center at San Antonio
1. Study Identification
Unique Protocol Identification Number
NCT00121537
Brief Title
Study to Determine the Utility of Wound Vacuum Assisted Closure (VAC) Compared to Conventional Saline Dressing Changes
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 Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Why Stopped
terminated, due to lack enrollment,
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds, Compartment Syndromes
Keywords
wounds-open
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Wound Care -Wound Vacuum Assisted Closure (VAC)
Intervention Type
Procedure
Intervention Name(s)
Wound Care - Wet to Dry Dressing Changes
Primary Outcome Measure Information:
Title
Rate of wound healing
Secondary Outcome Measure Information:
Title
Time to delayed primary wound closure
Title
Time to completion of secondary healing
Title
Patient satisfaction
Title
Nurse satisfaction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John G Myers, MD
Organizational Affiliation
The University of Texas Health Science Center at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-4493
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Determine the Utility of Wound Vacuum Assisted Closure (VAC) Compared to Conventional Saline Dressing Changes
We'll reach out to this number within 24 hrs