Breast CancerPhase 3NCT00161980
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
A Phase 3 study testing Fibrin Sealant VH S/D and Surgical intervention alone without Fibrin Sealant VH S/D application in people with Breast Cancer and Lumpectomy, run by Baxter Healthcare Corporation at 8 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Breast Cancer, Lumpectomy, Mastectomy Plus Axillary Lymph Node Dissection
- What is being tested?
- Fibrin Sealant VH S/D and Surgical intervention alone without Fibrin Sealant VH S/D application
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 8 sitesin 4 countries
- Study dates
- Jun 2001to Dec 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Germany3 sites
Ludwig-Maximilians-Universität
Munich, 80337
Universitätsklinikum Tübingen, Frauenklinik
Tübingen, 72076
Universitätsklinikum - Frauenklinik
Würzburg, 97080
Austria2 sites
Landeskrankenhaus St. Pölten
Sankt Pölten, Lower Austria, 3100
Allgemeines Krankenhaus der Stadt Wien, University Clinic for Gynecology
Vienna, 1090
Italy2 sites
S. Luigi - S. Curro, Presidi Ospedalieri Unificati
Catania, 95100
Istituto Nationale per la Ricerca sul Cancro
Genova, 16132
France1 site
Centre Régional de Lutte Contre le Cancer, Centre Eugène Marquis
Rennes, 35062
About this study
Official title: A Randomized and Controlled Clinical Study to Evaluate the Efficacy and Safety of Fibrin Sealant VH S/D (FS VH S/D) in Reduction of Lymphatic Leakage by Sealing Axillary Lymph Node Dissection Sites
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.
- Conditions
- Breast Cancer, Lumpectomy, Mastectomy Plus Axillary Lymph Node Dissection, Lymphatic Leakage
- Being tested
- Fibrin Sealant VH S/D, Surgical intervention alone without Fibrin Sealant VH S/D application
- Keywords
- Axillary wound, Seroma, Fistulae
- Medical subject headings
- Breast Neoplasms, Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrin Sealant VH S/DDrug
Surgical intervention alone without Fibrin Sealant VH S/D applicationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startJun 2001
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Andreas Berger, MD, Principal investigator, General Hospital / University Hospital Vienna, AustriaDiethelm Wallwiener, MD, Principal investigator, University of Tübingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161980
- Sponsor's protocol ID
- 550002
- Status last verified
- Oct 2006
- First submitted
- 8 Sep 2005
- Last updated
- 23 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized and Controlled Clinical Study to Evaluate the Efficacy and Safety of Fibrin Sealant VH S/D (FS VH S/D) in Reduction of Lymphatic Leakage by Sealing Axillary Lymph Node Dissection Sites
- ClinicalTrials.gov ID
- NCT00161980
- Acronym / sponsor ID
- 550002
- Conditions
- Breast Cancer, Lumpectomy, Mastectomy Plus Axillary Lymph Node Dissection, Lymphatic Leakage
- Keywords
- Axillary wound, Seroma, Fistulae
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2001
- Study completion
- Dec 2002
- First posted
- 13 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibrin Sealant VH S/D | Drug | – |
| Surgical intervention alone without Fibrin Sealant VH S/D application | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Berger, MD principal investigator
General Hospital / University Hospital Vienna, Austria
Diethelm Wallwiener, MD principal investigator
University of Tübingen, Germany
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fibrin Sealant VH S/D and Surgical intervention alone without Fibrin Sealant VH S/D application in people with Breast Cancer and Lumpectomy, run by Baxter Healthcare Corporation at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Austria, Italy, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2006.