Efficacy and Safety of FS VH S/D 4 S-apr for Flap Adherence in Rhytidectomy
Condition: Face-lift; Facial Rhytidectomy
Intervention: FS VH S/D 4 s-apr
Intervention description: FS VH S/D 4 s-apr will be applied (using spray device provided by Sponsor) to the subcutaneous plane (intraoperative, topical administration) in both the neck and the face area.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to compare the safety and efficacy of FS VH S/D 4 s-apr versus
      standard of care in adhering tissue and improving wound healing in subjects undergoing
      facelift.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subject is 18 to 75 years of age at the time of screening

          -  Subject is planned for facial rhytidectomy

          -  Subject has read, understood and signed the written informed consent

          -  Subject is healthy, as determined by the investigator using standard pre-operative
             assessments to include laboratory tests and electrocardiograms

          -  Subject is of childbearing potential, presents with a negative serum pregnancy test,
             and agrees to employ adequate birth control measures for the duration of the study

          -  Subject is willing and able to comply with the requirements of the protocol

        Exclusion Criteria:

          -  Subject is indicated for an abbreviated or modified face-lift procedure such as deep
             plane procedures, minimal undermining procedures, thread lifts, and minimal access
             cranial suspension

          -  Subject is indicated for concurrent facial surgeries during the operation (eg forehead
             plasty,blepharoplasty, rhinoplasty, buccal fat removal, any filler injections
             including fat injections, lip augmentation, skin resurfacing procedures etc.)

          -  Subject is indicated for additional procedures to the body during the same operation
             (eg liposuction, mastoplasty etc.)

          -  Subject has undergone a prior rhytidectomy surgery

          -  Subject is an active smoker, as assessed by the investigator

          -  Subject has a known (documented) bleeding or coagulation disorder

          -  Subject is being treated with anti-coagulants or with Aspirin (that was not
             discontinued 7 days prior to surgery)

          -  Subject has a vascular disorder, cardiovascular disease, and/or uncontrolled
             hypertension

          -  Subject has diabetes mellitus with glycosylated hemoglobin (HbA1c) > 7

          -  Subject is receiving active treatment for a malignancy

          -  Subject has a connective tissue disorder

          -  Subject has an active or chronic skin disorder

          -  Subject has history of Bell's palsy

          -  Subject has a documented history of pathologically or pharmacologically induced immune
             deficiency

          -  Subject has received chronic treatment with immunosuppressive drugs, systemic
             corticosteroids, or other chronic treatments within 30 days prior to the surgery

          -  Subject has a known sensitivity to components of FS VH S/D 4 s-apr

          -  Subject has a known psychiatric disorder (eg, obsessive compulsive disorder, anxiety,
             eating disorders, etc.)

          -  Subject has documented healing complications following previous surgeries (eg,
             hypertrophic scarring)

          -  Subject is pregnant or lactating at the time of enrollment

          -  Subject has participated in another clinical study involving an investigational
             product/device within 30 days prior to enrollment or is scheduled to participate in
             another clinical study involving an investigational product/device during the course
             of this study