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NCT00121537 Clinical Trial

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

Wounds Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00121537
Other study ID # 045-1502-226
Secondary ID
Status Terminated
Phase N/A
First received July 13, 2005
Last updated October 7, 2015
Start date July 2005
Est. completion date October 2006

Study information
Verified date October 2015
Source The University of Texas Health Science Center at San Antonio
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 30
Est. completion date October 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 99 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Wound Care -Wound Vacuum Assisted Closure (VAC)

Procedure:
• Wound Care - Wet to Dry Dressing Changes

Locations
Country Name City State
United States University Hospital San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of wound healing
Secondary Time to delayed primary wound closure
Secondary Time to completion of secondary healing
Secondary Patient satisfaction
Secondary Nurse satisfaction
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