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

Primary Purpose

Wounds and Injuries, Compartment Syndrome

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DermaClose fasciotomy closure
Vessel loop
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wounds and Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Missouri Hospital and Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Vessel Loop fasciotomy closure

DermaClose fasciotomy closure

Arm Description

Fasciotomy closure using vessel loops and staples.

Fasciotomy closure via DermaClose device

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain
Visual Analog Pain Scale (VAS) during initial hospitalization and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months
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
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.

Full Information

First Posted
July 27, 2010
Last Updated
January 3, 2018
Sponsor
University of Missouri-Columbia
Collaborators
Wound Care Technologies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01171534
Brief Title
Closure of Fasciotomy Wounds: A Prospective, Observational Study of a Continuous External Tissue Expander
Official Title
Closure of Fasciotomy Wounds: A Prospective, Observational Study of a Continuous External Tissue Expander
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
Study determined not to be feasible to continue.
Study Start Date
July 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
Collaborators
Wound Care Technologies, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds and Injuries, Compartment Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vessel Loop fasciotomy closure
Arm Type
Active Comparator
Arm Description
Fasciotomy closure using vessel loops and staples.
Arm Title
DermaClose fasciotomy closure
Arm Type
Experimental
Arm Description
Fasciotomy closure via DermaClose device
Intervention Type
Device
Intervention Name(s)
DermaClose fasciotomy closure
Other Intervention Name(s)
Continuous External Tissue Expander
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Vessel loop
Intervention Description
Vessel loops and staples for fasciotomy closure
Primary Outcome Measure Information:
Title
Performance of DermaClose System in Treatment of Fasciotomy Wounds
Description
Days to wound closure; number and types of procedures required for wound closure; infection requiring reoperation; wound dehiscence requiring reoperation
Time Frame
One year
Secondary Outcome Measure Information:
Title
Pain
Description
Visual Analog Pain Scale (VAS) during initial hospitalization and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months
Time Frame
One Year
Title
Quality of Life
Description
Quality of Life measured by the SF-12 version 1 at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months
Time Frame
One Year
Title
Cost-to-Benefit Ratio of DermaClose Versus Vessel Loop Fasciotomy Closure
Description
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.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory J Della Rocca, MD. PhD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri Hospital and Clinics
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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