Management of Complex Wounds Using a Constant Tension External Tissue Expander

Wounds and Injuries Clinical Trial

Official title:

Management of Complex Wounds Using a Constant Tension External Tissue Expander

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01171521
• Other study ID #: IRB1162777
• Status: Terminated
• Phase: N/A
• First received: July 27, 2010
• Last updated: January 27, 2016
• Start date: July 2010
• Est. completion date: September 2015

Study information

• Verified date: January 2016
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: September 2015
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	University of Missouri Hospital and Clinics	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	6 months	Yes