Double Blinded, Randomized Clinical Trial of the Twin Star ECSPRESS Monitoring System for the Reduction of the Incidence of Fasciotomy
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Double Blinded Study for the Reduction of the Incidence of Fasciotomy|
- Incidence of fasciotomies [ Time Frame: End of study once all subjects have completed their 12 month follow-up interval. ] [ Designated as safety issue: Yes ]
- Area under the curve (AUC) for time-pressure [ Time Frame: End of study once all subjects have completed their 12 month follow-up interval. ] [ Designated as safety issue: No ]
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Treatment are subjects will have catheter vacuum active for the removal of fluid from the muscle compartment.
|Device: ECSPRESS catheter with active vacuum|
No Intervention: Control
Treatment are subjects will have catheter vacuum in-active for the removal of fluid from the muscle compartment.
Eligible patients who are enrolled in the study will receive standard surgical stabilization within 72 hours of injury. All Subjects will receive the Twin Star ECSPRESS catheters, which will be inserted at the end of the surgical procedure to stabilize the tibia fracture and will be connected to the pressure monitor in the operating room or immediately upon arrival in the recovery room. The catheters will be used for up to 24-hours after surgical fixation of the affected lower leg in order to (1) measure and record muscle compartment pressure, and (2) remove interstitial fluid in the subset of subjects that are randomized to the Treatment Group. Subjects will be followed closely during the 24 hours the catheter is inserted to gather muscle pressure data, occurrance of a fasciotomy, adverse events, etc. and then followed up at 2 weeks, 3 months, 6 months and 12 months post study enrollment after which the subjects participation in the study will be completed. There will no interim data analysis of the study outcomes during the conduct of this study. Data analysis and presentation of the data will be made after study closure.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01879696
|Contact: David A Volgas, MD||573-882-6562 ext -----||firstname.lastname@example.org|
|Contact: James P Stannard, MD||573-884-7910 ext ------||email@example.com|
|United States, Missouri|
|University of Missouri-Columbia||Not yet recruiting|
|Columbia, Missouri, United States, 65212|
|Contact: Abigail K Stidham, LPN 573-882-7615 ext ---- firstname.lastname@example.org|
|Principal Investigator: David Volgas, MD|