Management of Complex Wounds Using a Constant Tension External Tissue Expander

NCT01171521 | Terminated Results

• 1 other identifier: IRB1162777
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Wounds and Injuries

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

• Pain

  6 months

Study Arms (1)

DermaClose Group

EXPERIMENTAL

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

Interventions

DermaClose Group DEVICE

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.

DermaClose Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or greater
• Has soft tissue wound(s) that are unable to be closed primarily

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri Hospital and Clinics

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Limitations and Caveats

enrollment was less than predicted and no subject completed the intended 12-month followup. Only SF-12 and pain data were collected for enrolled patients. There was also one screen failure.

Results Point of Contact

• Title: Brett Crist, MD
• Organization: University of Missouri, Department of Orthopaedics

cristb@health.missouri.edu

573-882-6562

Study Officials

• Brett D. Crist, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Co-Director of Trauma Services, Co-Director Trauma Fellowship, Department of Orthopaedic Surgery

Study Record Dates

• First Submitted: July 27, 2010
• First Posted: July 28, 2010
• Study Start: July 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: September 1, 2015
• Last Updated: February 26, 2016
• Results First Posted: January 9, 2015

Record last verified: 2016-01

Locations

US (1)