Efficacy and Safety Study of Fibrin Sealant With 4 IU/mL Thrombin, Vapor Heated, Solvent Detergent Treated (FS VH S/D 4) in Face-Lift Procedures

NCT ID: NCT00708071

Last Updated: 2012-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2008-09-30

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 participants undergoing a rhytidectomy (face-lift).

Conditions

Facial Rhytidectomy (Face-lift)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

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.

Group Type: EXPERIMENTAL

Fibrin Sealant with 4 IU/ml Thrombin, Vapor-Heated, Solvent Detergent Treated Containing Synthetic Aprotinin (FS VH S/D 4)

Intervention Type: BIOLOGICAL

Each subject received 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.)

Interventions

Fibrin Sealant with 4 IU/ml Thrombin, Vapor-Heated, Solvent Detergent Treated Containing Synthetic Aprotinin (FS VH S/D 4)

Each subject received 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.)

Intervention Type: BIOLOGICAL

Other Intervention Names

Fibrin Sealant; TISSEEL

Eligibility 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 Non-steroidal anti-inflammatory drug (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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steve Z Abrams, MD

Role: STUDY_DIRECTOR

Baxter Healthcare Corporation

Locations

Beverly Hills, California, United States

Los Angeles, California, United States

Atlanta, Georgia, United States

Evans, Georgia, United States

Hewlett, New York, United States

Chattanooga, Tennessee, United States

Countries

United States

References

Hester TR Jr, Gerut ZE, Shire JR, Nguyen DB, Chen AH, Diamond J, Desmond JC, Silvati-Fidell L, Abrams SZ. Exploratory, randomized, controlled, phase 2 study to evaluate the safety and efficacy of adjuvant fibrin sealant VH S/D 4 S-Apr (ARTISS) in patients undergoing rhytidectomy. Aesthet Surg J. 2013 Mar;33(3):323-33. doi: 10.1177/1090820X13477860.

Reference Type: DERIVED

PMID: 23515377 (View on PubMed)

Other Identifiers

550703

Identifier Type: -

Identifier Source: org_study_id