A Study Evaluating the Safety and Preliminary Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Elective Hepatic Surgery

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

May 12, 2021

Primary Completion Date

May 18, 2023

Study Completion Date

May 18, 2023

Conditions
HemostasisGeneral Surgery
Interventions
COMBINATION_PRODUCT

sFilm-FS

sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.

COMBINATION_PRODUCT

TACHOSIL®

TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Trial Locations (4)

1000

University Medical Center of Ljubljana, Division of Surgery, Ljubljana

1090

Medical University of Vienna, Department of Surgery Hepatobiliary Unit, Vienna

4010

Ordensklinikum Linz GmbH Barmherzige Schwestern, Linz

63100

Washington University in St. Louis, School of Medicine, Department of Surgery, St Louis

Sponsors
All Listed Sponsors
collaborator

Sintesi Research Srl

INDUSTRY

collaborator

Home Medics Consulting Ltd.

UNKNOWN

lead

Sealantium Medical Ltd.

INDUSTRY