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

This study has been terminated.
(A determination was made that this study is not feasible to continue and complete.)
Sponsor:
Collaborator:
Wound Care Technologies, Inc.
Information provided by (Responsible Party):
Gregory Della Rocca, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01171534
First received: July 27, 2010
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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 Intervention
Wounds and Injuries
Compartment Syndrome
Device: DermaClose Continuous External Tissue Expander
Device: Vessel loop

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Closure of Fasciotomy Wounds: A Prospective, Observational Study of a Continuous External Tissue Expander

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • Performance of DermaClose system in treatment of fasciotomy wounds [ Time Frame: One year ] [ Designated as safety issue: No ]
    Days to wound closure; number and types of procedures required for wound closure; infection requiring reoperation; wound dehiscence requiring reoperation


Secondary Outcome Measures:
  • Pain [ Time Frame: One Year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 7
Study Start Date: July 2010
Study Completion Date: February 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Continuous External Tissue Expander
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01171534

Locations
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.
Investigators
Principal Investigator: Gregory J Della Rocca, MD. PhD University of Missouri-Columbia
  More Information

No publications provided

Responsible Party: Gregory Della Rocca, Associate Professor, Co-Director of Trauma Services, Department of Orthopaedic Surgery, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01171534     History of Changes
Other Study ID Numbers: IRB1162817
Study First Received: July 27, 2010
Last Updated: March 4, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Compartment Syndromes
Wounds and Injuries
Muscular Diseases
Musculoskeletal Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 26, 2014