Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Baxter Healthcare Corporation |
---|---|
Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00708071 |
The primary objective of this study is to evaluate the efficacy and safety of fibrin sealant with 4 IU/mL thrombin, vapor heated, solvent detergent treated (FS VH S/D 4) when used to reduce early postoperative bruising in subjects undergoing a face-lift.
Condition | Intervention | Phase |
---|---|---|
Face-Lift Facial Rhytidectomy |
Drug: FS VH S/D 4 (Fibrin Sealant with 4 IU/mL Thrombin, Vapor Heated, Solvent Detergent Treated) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Exploratory Phase 2 Clinical Study to Evaluate Efficacy and Safety of the Adjuvant Use of Fibrin Sealant With 4 IU/mL Thrombin, Vapor Heated, Solvent Detergent Treated Containing Synthetic Aprotinin (FS VH S/D 4) in Subjects Undergoing Facial Rhytidectomy |
Enrollment: | 45 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | February 2009 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
|
Drug: FS VH S/D 4 (Fibrin Sealant with 4 IU/mL Thrombin, Vapor Heated, Solvent Detergent Treated)
Each subject will receive fibrin sealant with 4 IU/mL thrombin, vapor heated, solvent detergent treated containing synthetic aprotinin (FS VH S/D 4 ) to one side of the face. The dosing volume to be applied is 0.02 mL/cm2 to 0.04 mL/cm2. The study product will be applied to the subcutaneous plane in both the neck and the face area. The product will be applied using the spray device provided by the sponsor. (The other side of the face will be treated using standard of care.)
|
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
9201 Sunset Blvd. | |
Los Angeles, California, United States, 90069 | |
Facial Plastic & Reconstructive Surgery | |
Beverly Hills, California, United States, 90212 | |
United States, Georgia | |
The Georgia Center | |
Evans, Georgia, United States, 30809 | |
Paces Plastic Surgery | |
Atlanta, Georgia, United States, 30327 | |
United States, New York | |
The Medical Office of Zachary Gerut, MD | |
Hewlett, New York, United States, 11557 | |
United States, Tennessee | |
Shire Facial Plastic Surgery | |
Chattanooga, Tennessee, United States, 37421 |
Study Director: | Steve Z Abrams, MD | Baxter Healthcare Corporation |
Responsible Party: | Baxter Healthcare Corporation ( Steve Z. Abrams, MD; Medical Director ) |
Study ID Numbers: | 550703 |
Study First Received: | June 30, 2008 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00708071 |
Health Authority: | United States: Food and Drug Administration |
Thrombin Facies Fibrin Tissue Adhesive Aprotinin |
Coagulants Therapeutic Uses Hematologic Agents Pharmacologic Actions Hemostatics |