Management of Complex Wounds Using a Constant Tension External Tissue Expander

• Sponsor: University of Missouri-Columbia (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01171521
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Duration (Months): 62
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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	Phase
Wounds and Injuries	Device: DermaClose Group	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• 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: Jul 1, 2010
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Quality of Life [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None 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
• Other Study ID Numbers: IRB1162777
• First Posted: Jul 28, 2010
• Last Update Posted: Feb 26, 2016
• Last Verified: Jan 1, 2016

• Additional relevant MeSH terms: Wounds and Injuries

Study Results

Participant Flow

Arm/Group Title	DermaClose Group
Arm/Group Description	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. 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.
Period Title: Overall Study
STARTED	6
COMPLETED	0
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	DermaClose Group
Arm/Group Description	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. 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.
Overall Participants	6
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	6 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	1 16.7%
Male	5 83.3%

Outcome Measures

1. Primary Outcome

Title	Quality of Life
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DermaClose Group
Arm/Group Description	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. 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.
Measure Participants	5
Mean (Standard Deviation) [units on a scale]	62.2 (2.4)

2. Secondary Outcome

Title	Pain
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DermaClose Group
Arm/Group Description	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. 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.
Measure Participants	5
Mean (Standard Deviation) [units on a scale]	3.8 (3.1)

Adverse Events

Arm/Group Title	DermaClose Group
Arm/Group Description	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. 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.
All Cause Mortality
	DermaClose Group
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	DermaClose Group
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Other (Not Including Serious) Adverse Events
	DermaClose Group
	Affected / at Risk (%)	# Events
Total	0/5 (0%)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.