NCT00121537

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2005

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

October 8, 2015

Status Verified

October 1, 2015

First QC Date

July 13, 2005

Last Update Submit

October 7, 2015

Conditions

WoundsCompartment Syndromes

Keywords

wounds-open

Outcome Measures

Primary Outcomes (1)

  • Rate of wound healing

Secondary Outcomes (4)

  • Time to delayed primary wound closure

  • Time to completion of secondary healing

  • Patient satisfaction

  • Nurse satisfaction

Interventions

Wound Care -Wound Vacuum Assisted Closure (VAC)DEVICE
Wound Care - Wet to Dry Dressing ChangesPROCEDURE

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • inability to place wound VAC
  • contraindications for wound VAC use
  • pregnant females
  • prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

San Antonio, Texas, 78229-4493, United States

Location

MeSH Terms

Conditions

Wounds and InjuriesCompartment Syndromes

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • John G Myers, MD

    The University of Texas Health Science Center at San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 13, 2005

First Posted

July 21, 2005

Study Start

July 1, 2005

Study Completion

October 1, 2006

Last Updated

October 8, 2015

Record last verified: 2015-10

Locations

US(1)