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
Condition: Facial Rhytidectomy (Face-lift)
Intervention: Fibrin Sealant with 4 IU/ml Thrombin, Vapor-Heated, Solvent Detergent Treated Containing Synthetic Aprotinin (FS VH S/D 4)
Intervention description: 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 MeSH terms: Thrombin; Fibrin Tissue Adhesive; Aprotinin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

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).
    

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