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

Tracking Information

First Received Date ^ICMJE

June 30, 2008

Last Updated Date

January 9, 2009

Start Date ^ICMJE

June 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00708071 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Outcomes Assessor), Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Face-Lift
Facial Rhytidectomy

Intervention ^ICMJE

Drug: FS VH S/D 4 (Fibrin Sealant with 4 IU/mL Thrombin, Vapor Heated, Solvent Detergent Treated)

Study Arms / Comparison Groups

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.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

February 2009

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00708071

Responsible Party

Steve Z. Abrams, MD; Medical Director, Baxter Healthcare Corporation

Study ID Numbers ^ICMJE

550703

Study Sponsor ^ICMJE

Baxter Healthcare Corporation

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Steve Z Abrams, MD

Baxter Healthcare Corporation

Information Provided By

Baxter Healthcare Corporation

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP