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

• ClinicalTrials.gov Identifier: NCT01171534
• Recruitment Status: Terminated
• First Posted: July 28, 2010
• Results First Posted: December 10, 2014
• Last Update Posted: January 29, 2018
• Sponsor: University of Missouri-Columbia
• Collaborator: Wound Care Technologies, Inc.
• Information provided by (Responsible Party): Gregory Della Rocca, University of Missouri-Columbia

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

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

Additional relevant MeSH terms:

Compartment Syndromes; Wounds and Injuries; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases