Trial Outcomes & Findings for Closure of Fasciotomy Wounds: A Prospective, Observational Study of a Continuous External Tissue Expander (NCT NCT01171534)

Results Overview

Days to wound closure; number and types of procedures required for wound closure; infection requiring reoperation; wound dehiscence requiring reoperation

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

7 participants

Primary outcome timeframe

One year

Results posted on

2018-01-29

Participant Flow

Participant milestones

Participant milestones
Measure	Vessel Loop Fasciotomy Closure Fasciotomy closure using vessel loops and staples. Vessel loop: Vessel loops and staples for fasciotomy closure	DermaClose Fasciotomy Closure Fasciotomy closure via DermaClose device DermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed.
Overall Study STARTED	0	7
Overall Study COMPLETED	0	4
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Vessel Loop Fasciotomy Closure Fasciotomy closure using vessel loops and staples. Vessel loop: Vessel loops and staples for fasciotomy closure	DermaClose Fasciotomy Closure Fasciotomy closure via DermaClose device DermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed.
Overall Study Lost to Follow-up	0	2
Overall Study screen failure	0	1

Baseline Characteristics

Closure of Fasciotomy Wounds: A Prospective, Observational Study of a Continuous External Tissue Expander

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vessel Loop Fasciotomy Closure Fasciotomy closure using vessel loops and staples. Vessel loop: Vessel loops and staples for fasciotomy closure	DermaClose Fasciotomy Closure n=7 Participants Fasciotomy closure via DermaClose device DermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed.	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	—	7 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	—	7 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: One year

Population: Too low of an enrollment volume to analyze

Days to wound closure; number and types of procedures required for wound closure; infection requiring reoperation; wound dehiscence requiring reoperation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One Year

Population: too low of an enrollment volume to analyze

Visual Analog Pain Scale (VAS) during initial hospitalization and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One Year

Population: This study was terminated before any of this information was collected and analyzed.

Quality of Life measured by the SF-12 version 1 at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Population: This study was terminated before this information was collected and analyzed.

Costs associated with both types of closure (DermaClose and Vessel Loop) including hospital days, number of procedures, procedural and hospital costs including device(s), negative pressure wound therapy costs, and operating room time and associated costs.

Outcome measures

Outcome data not reported

Adverse Events

Vessel Loop Fasciotomy Closure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

DermaClose Fasciotomy Closure

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

Gregory J. Della Rocca, MD, PhD, FACS

University of Missouri, Department of Orthopaedic Surgery

Phone: 573-882-6562

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60