Management of Complex Wounds Using a Constant Tension External Tissue Expander

This study is currently recruiting participants.
Verified January 2014 by University of Missouri-Columbia
Sponsor:
Information provided by (Responsible Party):
Brett Crist, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01171521
First received: July 27, 2010
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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 Intervention
Wounds and Injuries
Device: DermaClose external tissue expander

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Management of Complex Wounds Using a Constant Tension External Tissue Expander

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • Performance of DermaClose system in treatment of complex soft-tissue wounds [ Time Frame: One year ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Superficial wound complications [ Time Frame: One year ] [ Designated as safety issue: No ]
    Superficial wound dehiscence and/or infection not requiring reoperation

  • Pain [ Time Frame: One year ] [ Designated as safety issue: No ]
    Visual Analog Pain Scale (VAS) with DermaClose use, and on study wound 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 use [ Time Frame: One year ] [ Designated as safety issue: No ]
    Costs associated with device use including hospital days, number of procedures, procedural and hospital costs including device, negative pressure wound therapy costs, and operating room time and associated costs


Estimated Enrollment: 50
Study Start Date: July 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 external tissue expander
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.

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 will be recorded.

Primary end points include:

  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

Secondary end points include:

  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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01171521

Contacts
Contact: Brett D. Crist, MD 573-882-6562 cristb@health.missouri.edu

Locations
United States, Missouri
University of Missouri Hospital and Clinics Recruiting
Columbia, Missouri, United States, 65212
Sub-Investigator: Gregory J. Della Rocca, MD         
Sub-Investigator: James Stannard, MD         
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Brett D. Crist, MD University of Missouri-Columbia
  More Information

No publications provided

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
Study First Received: July 27, 2010
Last Updated: January 29, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on April 17, 2014