Trial Outcomes & Findings for Management of Complex Wounds Using a Constant Tension External Tissue Expander (NCT NCT01171521)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

6 months

Results posted on

2016-02-26

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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 Study STARTED	6
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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 Study Lost to Follow-up	5
Overall Study screen failure	1

Baseline Characteristics

Management of Complex Wounds Using a Constant Tension External Tissue Expander

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DermaClose Group n=6 Participants 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.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	1 Participants n=93 Participants
Sex: Female, Male Male	5 Participants n=93 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	DermaClose Group n=5 Participants 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.
Quality of Life	62.2 units on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	DermaClose Group n=5 Participants 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.
Pain	3.8 units on a scale Standard Deviation 3.1

Adverse Events

DermaClose Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brett Crist, MD

University of Missouri, Department of Orthopaedics

Phone: 573-882-6562

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60