Double Blinded, Randomized Clinical Trial of the Twin Star ECSPRESS Monitoring System for the Reduction of the Incidence of Fasciotomy

NCT01879696 | Unknown DMC

• 2 other identifiers: 09-10000G110163
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study is a double-blinded, randomized clinical trial of tissue pressure monitoring only (Control group) vs. tissue pressure monitoring plus tissue ultrafiltration (Treatment group) in patients with tibia fractures presenting to the trauma or emergency departments at participating clinical sites. Tissue ultrafiltration refers to the removal of muscle interstitial fluid by the ECSPRESS PMFC. The primary objective of the study is to demonstrate whether the removal of interstitial fluid by the ECSPRESS PMFC/FC catheters decrease the incidence of fasciotomy in the Treatment group when compared to the Control group. Fasciotomy was chosen as the primary outcome because it is clearly defined and clinically relevant; reduction of fasciotomy is of clear clinical benefit. Enrolled patients may have isolated tibia fractures OR be multiple trauma patients (those with another major fracture in a different body region or two distinct body system injuries, excluding those with injuries to the opposite leg that would preclude them from completing required tests).

Conditions

Compartment Syndrome

Outcome Measures

Primary Outcomes (1)

• Incidence of fasciotomies

  End of study once all subjects have completed their 12 month follow-up interval.

Secondary Outcomes (1)

• Area under the curve (AUC) for time-pressure

  End of study once all subjects have completed their 12 month follow-up interval.

Study Arms (2)

Treatment

EXPERIMENTAL

Treatment are subjects will have catheter vacuum active for the removal of fluid from the muscle compartment.

Device: ECSPRESS catheter with active vacuum

Control

NO INTERVENTION

Treatment are subjects will have catheter vacuum in-active for the removal of fluid from the muscle compartment.

Interventions

ECSPRESS catheter with active vacuum DEVICE

Treatment

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• All Subjects
• Operative procedure (nailing or external fixation) performed within 72 hours of injury.
• The Subject is at least 18 years of age and no older than 44 years of age. Subject or legally acceptable representative must able to understand what he/she is being asked to do, willing/able to understand and sign the Informed Consent to return for the required follow-up visits at 2 weeks, 3 months, 6 months, and 12 months post-surgery. A legally acceptable representative may sign the Informed Consent on the patient's behalf.
• In the study investigators opinion, patient's co-morbidity condition(s) at enrollment WILL allow patient to return and complete the required testing for all return visits for the duration of this 12-month clinical study.
• Current evidence of CS prior to the decision regarding enrollment. Surgical stabilization that resulted in the presence of a bead pouch, VAC, negative-pressure wound therapy device, or other dressing that would interfere with placement of any of the four catheters in the anterior deep posterior compartments.
• The Subject has a medical condition(s) that precludes use of catheters, such as dermatologic conditions, immunological deficits, or traumatic skin lesions that interfere with Catheter placement.
• An Injury to the ipsilateral knee, ankle, and/or foot that would influence results of muscle testing.
• Opposite leg knee injury or tibia, ankle, foot fracture, or any other injury that would preclude or influence the results of mechanical muscle testing.
• Incision into the anterior or deep posterior compartments of the leg to be studied that would release the fascia as this would constitute a partial fasciotomy and would affect leg pressures.
• The Subject is currently enrolled in one or more clinical studies.
• Likely problems, in the investigator's judgment, with maintaining follow-up (including developmental delay, address greater than 2 hours drive from the treating institution, substance abuse problems, intoxication, current or pending incarceration, etc.).

Sponsors & Collaborators

• Twin Star Medical, Inc.: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Compartment Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

David A Volgas, MD

CONTACT

573-882-6562; volgasd@missouri.edu

James P Stannard, MD

CONTACT

573-884-7910; stannardj@health.missouri.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2013
• First Posted: June 18, 2013
• Study Start: June 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2015
• Last Updated: June 18, 2013

Record last verified: 2013-06

Locations

US (1)