Efficacy and Safety Study of FS VH S/D 4 in Face-Lift Procedures - Full Text View

Sponsored by:	Baxter Healthcare Corporation
Information provided by:	Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT00708071

Purpose

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

Drug Information available for: Aprotinin Fibrin Beriplast

U.S. FDA Resources

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

Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:

Visual comparison of ecchymosis at postoperative Day 3 between the FS VH S/D 4 -treated side of the face and the side treated using standard of care as assessed by 3 separate blinded reviewers using standard digital photographs [ Time Frame: Until the final follow-up visit at postoperative Day 14 (± 1) ] [ Designated as safety issue: No ]

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.)

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.)

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects planned for facial rhytidectomy
Subjects who read, understand and sign the written informed consent
Healthy female or male subjects as determined by the investigator using standard pre-operative assessments to include laboratory tests and ECG
Subjects 18-75 years old, inclusively
Subjects who are able and willing to comply with the protocol requirements
Female subjects of childbearing potential with a negative urine or serum pregnancy test within 72 hours of surgery

Exclusion Criteria:

Pregnant or lactating women
Subjects who have undergone previous face-lift surgery
Subjects undergoing abbreviated face-lift procedures such as deep plane procedures, minimal undermining procedures, thread lifts, and minimal access cranial suspension
Subjects indicated for concurrent facial surgeries during the operation (e.g. forehead plasty, blepharoplasty, rhinoplasty, buccal fat removal, any filler injections including fat injections, lip augmentation, skin resurfacing procedures etc.)
Subjects indicated for additional procedures during the same operation (e.g., liposuction, mastoplasty etc.)
Subjects who had prior silicone injections to their face (Botox and/or Restylane are allowed)
Subjects considered by the investigator to be smokers
Subjects with ecchymosis and/or edema on the face on day 0, prior to surgery
Subjects with known (documented) bleeding or coagulation disorders
Subjects currently being treated with anti-coagulants
Subjects treated with Aspirin in the last 7 days or use of other NSAIDs within the last 7 days prior to surgery
Subjects with vascular disorders, cardiovascular disease, and/or uncontrolled hypertension
Subjects with diabetes mellitus
Subjects with a history of Bell´s palsy
Subjects with connective tissue disorders
Subjects with documented history of pathologically or pharmacologically induced immune deficiency
Subjects receiving systemic corticosteroid treatment for a chronic condition within 2 to 30 days prior to the surgery
Subjects with a known sensitivity to fibrin sealants
Subjects with a known psychiatric disorder (e.g., depression, obsessive compulsive disorder, anxiety, eating disorders, etc)
Subjects who have participated in another clinical study within 30 days prior to this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00708071

Locations

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

Sponsors and Collaborators

Baxter Healthcare Corporation

Investigators

Study Director:

Steve Z Abrams, MD

Baxter Healthcare Corporation

More Information

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

Study placed in the following topic categories:

Thrombin
Facies
Fibrin Tissue Adhesive
Aprotinin

Additional relevant MeSH terms:

Coagulants
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions
Hemostatics

ClinicalTrials.gov processed this record on January 14, 2009