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Fibrin Sealant VH S/D 500 S-apr in Hepatic Resection

NCT01244425 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2013-02-20

Study results available
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Summary

The purpose of the study is to compare safety and efficacy of Fibrin Sealant (FS) Vapor Heated (VH) S/D 500 s-apr with manual compression as a supportive treatment of local bleeding (i.e. oozing) in hepatic resection surgery when standard surgical techniques are insufficient.

Conditions

  • Bleeding (Oozing) in Hepatic Resection

Interventions

DRUG

Fibrin Sealant (FS) VH S/D 500 s-apr

Dosage form: spray application; dosage frequency: single application

OTHER

Manual compression

Dosage form: surgical gauze swab; dosage frequency: single application

Sponsors & Collaborators

  • Baxter Innovations GmbH

    collaborator INDUSTRY

  • Baxter Healthcare Corporation

    lead INDUSTRY

Principal Investigators

  • Baxter BioScience Medical Director, MD · Baxter Healthcare Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • Germany

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 NCT01244425 on ClinicalTrials.gov