Closure of Fasciotomy Wounds: A Prospective, Observational Study of a Continuous External Tissue Expander
|ClinicalTrials.gov Identifier: NCT01171534|
Recruitment Status : Terminated (Study determined not to be feasible to continue.)
First Posted : July 28, 2010
Results First Posted : December 10, 2014
Last Update Posted : January 29, 2018
Fasciotomy wounds are rarely able to be closed at the time of index surgery. They often require multiple returns to surgery for closure, and occasionally require skin grafting (i.e. they are never completely closed). We are interested in seeing whether this device, which provides constant and gradual tension on the wound, may allow for rapid wound closure in a safe fashion, perhaps even precluding a return trip to surgery.
Null hypothesis #1: The Dermaclose Wound Management System (Woundcare Technologies Inc, Chanhassen, Minnesota) will not result in closure of fasciotomy wounds more rapidly than standard vessel loop techniques.
Null hypothesis #2: The Dermaclose Wound Management System will not reduce the number of return trips to the operating room for surgical procedures related to closure or skin grafting of fasciotomy wounds.
|Condition or disease||Intervention/treatment||Phase|
|Wounds and Injuries Compartment Syndrome||Device: DermaClose fasciotomy closure Device: Vessel loop||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Closure of Fasciotomy Wounds: A Prospective, Observational Study of a Continuous External Tissue Expander|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||February 2014|
Active Comparator: Vessel Loop fasciotomy closure
Fasciotomy closure using vessel loops and staples.
Device: Vessel loop
Vessel loops and staples for fasciotomy closure
Experimental: DermaClose fasciotomy closure
Fasciotomy closure via DermaClose device
Device: DermaClose fasciotomy closure
The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed.
Other Name: Continuous External Tissue Expander
- Performance of DermaClose System in Treatment of Fasciotomy Wounds [ Time Frame: One year ]Days to wound closure; number and types of procedures required for wound closure; infection requiring reoperation; wound dehiscence requiring reoperation
- Pain [ Time Frame: One Year ]Visual Analog Pain Scale (VAS) during initial hospitalization and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months
- Quality of Life [ Time Frame: One Year ]Quality of Life measured by the SF-12 version 1 at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months
- Cost-to-Benefit Ratio of DermaClose Versus Vessel Loop Fasciotomy Closure [ Time Frame: One year ]Costs associated with both types of closure (DermaClose and Vessel Loop) including hospital days, number of procedures, procedural and hospital costs including device(s), negative pressure wound therapy costs, and operating room time and associated costs.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01171534
|United States, Missouri|
|University of Missouri Hospital and Clinics|
|Columbia, Missouri, United States, 65212|
|Principal Investigator:||Gregory J Della Rocca, MD. PhD||University of Missouri-Columbia|