The Paediatric EVICEL® Soft Tissue and Parenchymal Organ Bleeding Study

PHASE3CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

August 1, 2014

Primary Completion Date

April 17, 2019

Study Completion Date

May 17, 2019

Conditions
HemorrhageSoft Tissue Bleeding
Interventions
BIOLOGICAL

EVICEL® Fibrin Sealant

EVICEL® is a human plasma-derived fibrin sealant. EVICEL® consists of two components: a concentrate of Human Clottable Protein (referred to as Biological Component 2; BAC2) and a solution of Human Thrombin. No material of animal origin is present in the product

DEVICE

SURGICEL® Absorbable Hemostat

SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.

Trial Locations (13)

Unknown

Clinical Investigation Site #31, Brussels

Clinical Investigation Site #42, Hamilton

Clinical Investigation Site #40, Toronto

Clinical Investigation Site #41, Montreal

Clinical Investigation Site #21, Birmingham

Clinical Investigation Site #22, Leeds

Clinical Investigation Site #20, Liverpool

Clinical Investigation Site #23, London

Clinical Investigation Site #26, London

Clinical Investigation Site #30, Newcastle

Clinical Investigation Site #24, Southampton

SE1 7EH

Clinical Investigation Site #27, London

NG7 2UH

Clinical Investigation Site #25, Nottingham

All Listed Sponsors
lead

Ethicon, Inc.

INDUSTRY

NCT02227706 - The Paediatric EVICEL® Soft Tissue and Parenchymal Organ Bleeding Study | Biotech Hunter | Biotech Hunter