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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Wounds and Injuries, Compartment Syndrome

Intervention / Treatment
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* Device: DermaClose fasciotomy closure
* Device: Vessel loop


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vessel Loop fasciotomy closure<br>Fasciotomy closure using vessel loops and staples. | Device: Vessel loop<br>* Vessel loops and staples for fasciotomy closure<br>|
| Experimental: DermaClose fasciotomy closure<br>Fasciotomy closure via DermaClose device | Device: DermaClose fasciotomy closure<br>* 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.<br>* Other names: Continuous External Tissue Expander;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of DermaClose System in Treatment of Fasciotomy Wounds | Days to wound closure; number and types of procedures required for wound closure; infection requiring reoperation; wound dehiscence requiring reoperation | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Visual Analog Pain Scale (VAS) during initial hospitalization and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months | One Year | 
| Quality of Life | Quality of Life measured by the SF-12 version 1 at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months | One Year | 
| Cost-to-Benefit Ratio of DermaClose Versus Vessel Loop Fasciotomy Closure | 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. | One year |