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

NCT01879696 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2013-06-18

No results posted yet for this study

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

Interventions

DEVICE

ECSPRESS catheter with active vacuum

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Twin Star Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-05-31
Completion
2015-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01879696 on ClinicalTrials.gov