Closure of Fasciotomy Wounds: A Prospective, Observational Study of a Continuous External Tissue Expander
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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 |
- 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
- 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.
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2012 (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 |
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| Contact: Gregory J. Della Rocca, MD | 573-882-6562 | dellaroccag@health.missouri.edu |
| United States, Missouri | |
| University of Missouri Hospital and Clinics | Recruiting |
| Columbia, Missouri, United States, 65212 | |
| Principal Investigator: Gregory J. Della Rocca, MD | |
| Sub-Investigator: Brett D. Crist, MD | |
| Sub-Investigator: James Stannard, MD | |
| Principal Investigator: | Gregory J Della Rocca, MD. PhD | University of Missouri-Columbia |
More Information
No publications provided
| Responsible Party: | Gregory J. Della Rocca, MD, University of Missouri |
| ClinicalTrials.gov Identifier: | NCT01171534 History of Changes |
| Other Study ID Numbers: | IRB1162817 |
| Study First Received: | July 27, 2010 |
| Last Updated: | March 2, 2011 |
| 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 May 23, 2013