Closure of Fasciotomy Wounds: A Prospective, Observational Study of a Continuous External Tissue Expander

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Wound Care Technologies, Inc.
Information provided by (Responsible Party):
Gregory Della Rocca, University of Missouri-Columbia

Brief Summary:

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

Detailed Description:
After IRB approval, all patients meeting inclusion criteria and requiring fasciotomy of the arms, legs, or pelvis will be consented for participation in the research study. Patients will either have their fasciotomy wounds closed through application of the Dermaclose device, as per the manufacturer's instructions, or through application of vessel loops with staples in a "shoestring technique" as described in the literature (1). Choice of wound closure technique will be at surgeon discretion. All patients will undergo application of a vacuum-assisted wound closure device (Wound VAC, Active Healing Solutions Inc, San Antonio, TX), which is standard of care for temporary coverage of open wounds (2, 3). Patients will be returned to the operating room every 2-3 days until wound closure or skin grafting has been accomplished. If skin closure is not accomplished in the operating room, but occurs prior to return trip to the operating room, then definitive suture closure of the wound will be performed under local anaesthetic, followed by removal of the Dermaclose device or of the vessel loop with staple shoestring. Decisions regarding wound closure or skin grafting in the operating room will be left to the judgment of the attending surgeon.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients 18 years of age or older
  • Patients undergoing fasciotomy for decompression of compartment syndrome, evolving compartment syndrome, or prophylactically to prevent compartment syndrome

Exclusion Criteria:

  • Patient younger than 18 years of age
  • Patients with an active infection
  • Patients unable to comply with protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01171534

United States, Missouri
University of Missouri Hospital and Clinics
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Wound Care Technologies, Inc.
Principal Investigator: Gregory J Della Rocca, MD. PhD University of Missouri-Columbia

Responsible Party: Gregory Della Rocca, Associate Professor, Co-Director of Trauma Services, Department of Orthopaedic Surgery, University of Missouri-Columbia Identifier: NCT01171534     History of Changes
Other Study ID Numbers: IRB1162817
First Posted: July 28, 2010    Key Record Dates
Results First Posted: December 10, 2014
Last Update Posted: January 29, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Wounds and Injuries
Compartment Syndromes
Muscular Diseases
Musculoskeletal Diseases
Vascular Diseases
Cardiovascular Diseases
Glucuronyl glucosamine glycan sulfate
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs