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

NCT ID: NCT01171534

Last Updated: 2018-01-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2014-02-28

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.

Detailed Description

After IRB approval, all patients meeting inclusion criteria and requiring fasciotomy of the arms, legs, or pelvis will be consented for participation in the research study. Patients will either have their fasciotomy wounds closed through application of the Dermaclose device, as per the manufacturer's instructions, or through application of vessel loops with staples in a "shoestring technique" as described in the literature (1). Choice of wound closure technique will be at surgeon discretion. All patients will undergo application of a vacuum-assisted wound closure device (Wound VAC, Active Healing Solutions Inc, San Antonio, TX), which is standard of care for temporary coverage of open wounds (2, 3). Patients will be returned to the operating room every 2-3 days until wound closure or skin grafting has been accomplished. If skin closure is not accomplished in the operating room, but occurs prior to return trip to the operating room, then definitive suture closure of the wound will be performed under local anaesthetic, followed by removal of the Dermaclose device or of the vessel loop with staple shoestring. Decisions regarding wound closure or skin grafting in the operating room will be left to the judgment of the attending surgeon.

Conditions

Wounds and Injuries; Compartment Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vessel Loop fasciotomy closure

Fasciotomy closure using vessel loops and staples.

Group Type: ACTIVE_COMPARATOR

Vessel loop

Intervention Type: DEVICE

Vessel loops and staples for fasciotomy closure

DermaClose fasciotomy closure

Fasciotomy closure via DermaClose device

Group Type: EXPERIMENTAL

DermaClose fasciotomy closure

Intervention Type: 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.

Interventions

DermaClose fasciotomy closure

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.

Intervention Type: DEVICE

Vessel loop

Vessel loops and staples for fasciotomy closure

Intervention Type: DEVICE

Other Intervention Names

Continuous External Tissue Expander

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wound Care Technologies, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Gregory Della Rocca

Associate Professor, Co-Director of Trauma Services, Department of Orthopaedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gregory J Della Rocca, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

University of Missouri Hospital and Clinics

Columbia, Missouri, United States

Countries

United States

Other Identifiers

IRB1162817

Identifier Type: -

Identifier Source: org_study_id