Management of Complex Wounds Using a Constant Tension External Tissue Expander
Primary Purpose
Wounds and Injuries
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DermaClose Group
Sponsored by
About this trial
This is an interventional treatment trial for Wounds and Injuries
Eligibility Criteria
Inclusion Criteria:
- Age 18 or greater
- Has soft tissue wound(s) that are unable to be closed primarily
Exclusion Criteria:
- Age less than 18
- Has wound(s) that can be closed primarily
- Infected wound
- Unable to comply with protocol
- Prior radiation treatment to skin or soft tissues in the area of the wound
- Friable wound margins
Sites / Locations
- University of Missouri Hospital and Clinics
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DermaClose Group
Arm Description
DermaClose device applied to complex soft-tissue wound, with or without negative pressure wound therapy, and prospectively followed for primary and secondary outcomes for one year.
Outcomes
Primary Outcome Measures
Quality of Life
The SF-12 contains 12 items from the SF-36 Health Survey - . The SF-12 contains one or two items that measure each of the eight concepts included in the SF-36.
The Quality of Life SF-12 is a scale from 0 - 100, in which 0 = poor functioning and 100 = excellent functioning.
Secondary Outcome Measures
Pain
Visual Analog Pain Scale (VAS) with DermaClose use, and on study wound at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months. The scale goes from 0 to 10 with 0 being no pain and 10 being the most severe pain imaginable. It is a visual analog scale so is continuous data.
Full Information
NCT ID
NCT01171521
First Posted
July 27, 2010
Last Updated
January 27, 2016
Sponsor
University of Missouri-Columbia
1. Study Identification
Unique Protocol Identification Number
NCT01171521
Brief Title
Management of Complex Wounds Using a Constant Tension External Tissue Expander
Official Title
Management of Complex Wounds Using a Constant Tension External Tissue Expander
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
enrollment did not meet projections and numerous lost to follow-up
Study Start Date
July 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Complex wounds that cannot be closed primarily are at great risk for complications. A new technique utilizing external tissue expansion holds promise in rapidly decreasing wound area. Facilitation of rapid wound closure is critical in preventing wound complications.
Hypothesis:
Using the Dermaclose Wound Management System (Woundcare Technologies, Inc., Chanhassen, MN) in complex wounds not able to be primarily closed will decrease the time to secondary closure and decrease the need for secondary soft tissue coverage procedures, or if secondary soft tissue procedures are required, its use will decrease the size and complexity of the secondary soft tissue procedures.
Null Hypothesis:
The Dermaclose system will not decrease the need, dimensions, or complexity of secondary soft tissue coverage procedures in complex wounds not able to be primarily closed.
Detailed Description
Upon IRB approval, 50 patients with complex soft tissue wounds, with or without an associated fracture that cannot be closed primarily will have the Dermaclose device applied and will be prospectively followed for 1 year. The Dermaclose device will be applied according to the manufacturer's guidelines. This device may be combined with the use of Negative Pressure Wound Therapy. Primary and secondary end points that were initially intended to be included are listed below. However, on SF12 and pain outcome measures were collected and reported.
Initially Intended Primary end points (only SF12 collected and reported):
SF12
Initial and final wound dimensions
Secondary soft tissue coverage procedures
Dimensions and type of secondary soft tissue coverage procedures required compared to initial wound dimensions
Method of wound closure
Days to wound closure
Number and types of procedures required for wound closure
Infection requiring reoperation
Wound dehiscence requiring reoperation
Initially intended Secondary end points (only #3 collected and reported):
Superficial wound dehiscence not requiring reoperation
Superficial wound infection not requiring reoperation
Visual Analog Pain Scale (VAS) with Dermaclose use
Use of negative pressure wound therapy
Cost-to-benefit ratio of Dermaclose use - hospital days, number of procedures, procedural and hospital costs including device, negative pressure wound therapy costs, and operating room time and associated costs
Patients will be evaluated daily during their inpatient hospital stays for VAS related to the wound for which the Dermaclose device is used. If the Dermaclose device is used on an outpatient basis, the patient will be asked to complete a daily VAS at the same time to monitor pain associated with device use. After hospital discharge, the patients will be evaluated at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months. They will complete an SF-12 as part of the above evaluations. Patients may be evaluated at more frequent intervals if the need arises. Primary and secondary endpoints will be evaluated at each time point.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds and Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DermaClose Group
Arm Type
Experimental
Arm Description
DermaClose device applied to complex soft-tissue wound, with or without negative pressure wound therapy, and prospectively followed for primary and secondary outcomes for one year.
Intervention Type
Device
Intervention Name(s)
DermaClose Group
Intervention Description
The DermaClose external tissue expander provides continuous expanding of the skin around a wound until it has stretched enough to suture the wound edges closed.
Primary Outcome Measure Information:
Title
Quality of Life
Description
The SF-12 contains 12 items from the SF-36 Health Survey - . The SF-12 contains one or two items that measure each of the eight concepts included in the SF-36.
The Quality of Life SF-12 is a scale from 0 - 100, in which 0 = poor functioning and 100 = excellent functioning.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Pain
Description
Visual Analog Pain Scale (VAS) with DermaClose use, and on study wound at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months. The scale goes from 0 to 10 with 0 being no pain and 10 being the most severe pain imaginable. It is a visual analog scale so is continuous data.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 or greater
Has soft tissue wound(s) that are unable to be closed primarily
Exclusion Criteria:
Age less than 18
Has wound(s) that can be closed primarily
Infected wound
Unable to comply with protocol
Prior radiation treatment to skin or soft tissues in the area of the wound
Friable wound margins
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brett D. Crist, MD
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
Management of Complex Wounds Using a Constant Tension External Tissue Expander
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