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Management of Complex Wounds Using a Constant Tension External Tissue Expander

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ClinicalTrials.gov Identifier: NCT01171521
Recruitment Status : Terminated (enrollment did not meet projections and numerous lost to follow-up)
First Posted : July 28, 2010
Results First Posted : January 9, 2015
Last Update Posted : February 26, 2016
Sponsor:
Information provided by (Responsible Party):
Brett Crist, University of Missouri-Columbia

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.


Condition or disease Intervention/treatment
Wounds and Injuries Device: DermaClose Group

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

  1. Initial and final wound dimensions
  2. Secondary soft tissue coverage procedures
  3. Dimensions and type of secondary soft tissue coverage procedures required compared to initial wound dimensions
  4. Method of wound closure
  5. Days to wound closure
  6. Number and types of procedures required for wound closure
  7. Infection requiring reoperation
  8. Wound dehiscence requiring reoperation

Initially intended Secondary end points (only #3 collected and reported):

  1. Superficial wound dehiscence not requiring reoperation
  2. Superficial wound infection not requiring reoperation
  3. Visual Analog Pain Scale (VAS) with Dermaclose use
  4. Use of negative pressure wound therapy
  5. 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Management of Complex Wounds Using a Constant Tension External Tissue Expander
Study Start Date : July 2010
Primary Completion Date : October 2013
Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: DermaClose Group
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.
Device: DermaClose Group
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 Measures :
  1. Quality of Life [ Time Frame: 6 months ]

    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 :
  1. Pain [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01171521


Locations
United States, Missouri
University of Missouri Hospital and Clinics
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Brett D. Crist, MD University of Missouri-Columbia

Responsible Party: Brett Crist, Assistant Professor, Co-Director of Trauma Services, Co-Director Trauma Fellowship, Department of Orthopaedic Surgery, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01171521     History of Changes
Other Study ID Numbers: IRB1162777
First Posted: July 28, 2010    Key Record Dates
Results First Posted: January 9, 2015
Last Update Posted: February 26, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Wounds and Injuries