NCT04419597View on ClinicalTrials.gov

Hemopatch Safety and Efficacy Evaluation Versus Standard Practice for Sealing the Dura in Cerebrospinal Fluid Leaks

NACompletedINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

November 2, 2020

Primary Completion Date

July 15, 2024

Study Completion Date

July 15, 2024

Conditions
Surgery
Interventions
DEVICE

HEMOPATCH

The treatment will be performed with the HEMOPATCH collagen patch and hemostatic PEG sealant (Baxter), applying two units of the large patch to reinforce the primary dural closure (HEMOPATCH 4.5x9cm, 1506253).

DEVICE

Standard of care

Usual clinical practice techniques for reinforcing primary dural closure.

Trial Locations (1)

28034

Hospital Ramón y Cajal, Madrid

All Listed Sponsors
lead

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

OTHER

NCT04419597 - Hemopatch Safety and Efficacy Evaluation Versus Standard Practice for Sealing the Dura in Cerebrospinal Fluid Leaks | Biotech Hunter | Biotech Hunter