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Evaluation of Fibrin Sealant 2 in Retroperitoneal or Intra-Abdominal Surgery

NCT00307515 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2009-01-09

No results posted yet for this study

Summary

A comparison of fibrin sealant 2 versus Surgicel® as an addition to standard surgical practice in stopping mild to moderate soft tissue bleeding during retroperitoneal or intra-abdominal surgery.

Conditions

  • Blood Loss, Surgical

Interventions

DRUG

Fibrin Sealant 2 (FS2)

FS2 Surgical Sealant Kit: Biological Active Component containing Human Fibrinogen 55-85 mg/mL and Thrombin containing Thrombin 800-1200 IU/mL and Calcium Chloride 5.6-6.2 mg/mL

DEVICE

Oxidized Regenerated Cellulose (Surgicel)

Commercially available Surgicel used within label.

Sponsors & Collaborators

  • OMRIX Biopharmaceuticals

    collaborator INDUSTRY

  • Ethicon, Inc.

    lead INDUSTRY

Principal Investigators

  • James Hart, MD · Ethicon, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2006-12-31
Completion
2006-12-31

Countries

  • United States

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 NCT00307515 on ClinicalTrials.gov