Efficacy and Safety of Fibrin Sealant Vapor Heated Solven... | NCT00161980

Studies
Efficacy and Safety of Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D) for Reduction of Lymphatic Leakage by Sealing Axillary Lymph Node Dissection Sites

NCT00161980

Sponsor

Baxter Healthcare Corporation

Status

Completed

Last Update Posted

Oct 23, 2006Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Breast Cancer
Lumpectomy
Mastectomy Plus Axillary Lymph Node Dissection
Lymphatic Leakage

Interventions

Fibrin Sealant VH S/D
Surgical intervention alone without Fibrin Sealant VH S/D application

Countries

Austria
France
Germany
Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Oct 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2001

Primary Completion Date

Not provided

Completion Date

Dec 2002

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 13, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2006

Last Update Posted Date

Oct 23, 2006Estimated

Description Module

Brief Summary

This study will monitor the safety of FS VH S/D and will evaluate whether FS VH S/D is superior to conventional surgical procedures in the reduction of lymphatic leakage by sealing the axillary lymphatics in subjects undergoing lumpectomy and level I and II axillary lymph node dissection with two separate incisions.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent has been obtained from the subject prior to FS VH S/D administration
Female subjects >= 19 years of age
Subjects with breast cancer scheduled to undergo lumpectomy of the breast and level I and II axillary lymphadenectomy with two separate incisions

Exclusion Criteria:

Subjects with known hypersensitivity to aprotinin or other components of the product
Subjects with immunodeficiency
Subjects with increased red cell production (e.g., in hemolytic anemia)
Subjects with coagulation disorders shown by exceeding the normal range of any of following: prothrombin time (PT), Quick, activated partial thromboplastin time (aPTT), fibrinogen level, or thrombocytes.
Subjects having previously had axillary surgery
Subjects having undergone irradiation therapy to the axillary tissue
Subjects having ever received chemotherapy before the surgery

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andreas Berger, MD	General Hospital / University Hospital Vienna, Austria	Principal Investigator
Diethelm Wallwiener, MD	University of Tübingen, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Landeskrankenhaus St. Pölten		Sankt Pölten	Lower Austria	3100	Austria
Allgemeines Krankenhaus der Stadt Wien, University Clinic for Gynecology

ID	Term
D001943	Breast Neoplasms
D049291	Seroma

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D007249	Inflammation
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Name	Type	Description	Arm Group Labels	Other Names
Fibrin Sealant VH S/D	Drug
Surgical intervention alone without Fibrin Sealant VH S/D application	Procedure