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

NCT01171534 | Terminated Results

• 1 other identifier: IRB1162817
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Fasciotomy wounds are rarely able to be closed at the time of index surgery. They often require multiple returns to surgery for closure, and occasionally require skin grafting (i.e. they are never completely closed). We are interested in seeing whether this device, which provides constant and gradual tension on the wound, may allow for rapid wound closure in a safe fashion, perhaps even precluding a return trip to surgery. Null hypothesis #1: The Dermaclose Wound Management System (Woundcare Technologies Inc, Chanhassen, Minnesota) will not result in closure of fasciotomy wounds more rapidly than standard vessel loop techniques. Null hypothesis #2: The Dermaclose Wound Management System will not reduce the number of return trips to the operating room for surgical procedures related to closure or skin grafting of fasciotomy wounds.

Conditions

Wounds and Injuries; Compartment Syndrome

Outcome Measures

Primary Outcomes (1)

• Performance of DermaClose System in Treatment of Fasciotomy Wounds

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

  One year

Secondary Outcomes (3)

• Pain

  One Year

• Quality of Life

  One Year

• Cost-to-Benefit Ratio of DermaClose Versus Vessel Loop Fasciotomy Closure

  One year

Study Arms (2)

Vessel Loop fasciotomy closure

ACTIVE COMPARATOR

Fasciotomy closure using vessel loops and staples.

Device: Vessel loop

DermaClose fasciotomy closure

EXPERIMENTAL

Fasciotomy closure via DermaClose device

Device: DermaClose fasciotomy closure

Interventions

DermaClose fasciotomy closure DEVICE

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.

Also known as: Continuous External Tissue Expander

DermaClose fasciotomy closure

Vessel loop DEVICE

Vessel loops and staples for fasciotomy closure

Vessel Loop fasciotomy closure

Eligibility Criteria

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

You may qualify if:

• Patients 18 years of age or older
• Patients undergoing fasciotomy for decompression of compartment syndrome, evolving compartment syndrome, or prophylactically to prevent compartment syndrome

You may not qualify if:

• Patient younger than 18 years of age
• Patients with an active infection
• Patients unable to comply with protocol

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• Wound Care Technologies, Inc.: collaborator

Study Sites (1)

University of Missouri Hospital and Clinics

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Compartment Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Gregory J. Della Rocca, MD, PhD, FACS
• Organization: University of Missouri, Department of Orthopaedic Surgery

dellaroccag@health.missouri.edu

573-882-6562

Study Officials

• Gregory J Della Rocca, MD. PhD

  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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Co-Director of Trauma Services, Department of Orthopaedic Surgery

Study Record Dates

• First Submitted: July 27, 2010
• First Posted: July 28, 2010
• Study Start: July 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: February 1, 2014
• Last Updated: January 29, 2018
• Results First Posted: December 10, 2014

Record last verified: 2018-01

Locations

US (1)