Management of Complex Wounds Using a Constant Tension External Tissue Expander

This study has been terminated.
(enrollment did not meet projections and numerous lost to follow-up)
Sponsor:
Information provided by (Responsible Party):
Brett Crist, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01171521
First received: July 27, 2010
Last updated: January 7, 2015
Last verified: January 2015
  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 Group

Study Type: Interventional
Study Design: 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

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

Primary Outcome Measures:
  • Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 6
Study Start Date: July 2010
Estimated Study Completion Date: September 2015
Primary Completion Date: October 2013 (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 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.

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  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
Results First Received: September 12, 2014
Last Updated: January 7, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on May 27, 2015