Efficacy and Safety of ARTISS for Flap Adherence in Abdominoplasty
Condition: Seroma; Hematoma
MeSH terms: Hematoma; Seroma
Intervention: FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma); Standard of care
Intervention description: Dosage form: spray (aerosolized sealant), Dosage frequency: once (1 layer). ARTISS will be applied onto the fascia or the wound bed.; Standard of care
Intervention MeSH terms: Fibrin Tissue Adhesive
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Abdominoplasty; Flap adherence in subjects undergoing abdominoplasty to eliminate dead space and reduce seroma/hematoma formation

Summary:

      The purpose of the study is to compare the safety and efficacy of ARTISS versus standard of
      care in adhering tissue places and reducing seroma/hematoma formation in subjects undergoing
      abdominoplasty.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is 18 to 75 years of age at the time of screening

          -  Subject is planned for primary standard abdominoplasty (status post Cesarean section
             or liposuction performed more than 6 months prior to enrollment in the study are
             allowed)

          -  If the subject is of childbearing potential; presents with a negative pregnancy test,
             and agrees to employ adequate birth control measures for the duration of the study

          -  Subject resides within 100 miles of the investigational site and is willing and able
             to comply with the scheduling requirements of the protocol (notably home visits by
             study personnel)

          -  Subject is willing and able to comply with the requirements of the protocol

        Exclusion Criteria:

          -  Subject is obese (body mass index [BMI] > 30 before surgery)

          -  Subject has experienced massive weight loss (subject has a history of obesity during
             adult life; subject lost more than 20 BMI unit score, subject has undergone a
             bariatric surgery)

          -  Subject has a history of active smoking within the previous 12 months

          -  Subject is elected for a non-standard abdominoplasty (extended, limited or
             mini-abdominoplasty, endoscopic, fleur-de-lis or circumferential abdominoplasty) or
             panniculectomy

          -  Subject has scars on the abdominal wall above the umbilicus. Vertical midline,
             laparoscopic punctures, or liposuction punctures are permitted

          -  Subject is planned for other "body lifting" procedures (eg to the arms, legs, back
             etc.)

          -  Subject is planned for combined abdominoplasty with other cosmetic procedures
             including liposuction (restricted liposuction of the waist line and the lower back is
             allowed, as long as the integrity of the surgical spaces is maintained)

          -  Subject has an active or chronic skin disorder, history or evidence of keloid
             formation, or hypertrophic scarring

          -  Subject has a history of gastrointestinal disorders (eg Irritable Bowel Syndrome)
             requiring prescription medications

          -  Subject has a known abdominal hernia that requires mesh fixation

          -  Subject has a documented hiatal hernia or acid reflux disease

          -  Subjects with congenital or acquired immunodeficiency disorders

          -  Subject has uncontrolled diabetes mellitus (HbA1c > 7.0)

          -  Subject has a history of cardio-vascular disease including uncontrolled hypertension
             (> 140/90 mm Hg)

          -  Subject has a clinically diagnosed psychiatric disorder (including obsessive
             compulsive disorders)

          -  Subject has a known (documented) bleeding or coagulation disorder including history of
             thromboembolic events

          -  Subject is being treated with anti-coagulants or with Aspirin (that was not
             discontinued 7 days prior to surgery)

          -  Subject is receiving active treatment for a malignancy

          -  Subject has a connective tissue disorder

          -  Subject has received chronic treatment with immunosuppressive drugs, systemic
             corticosteroids, or other chronic treatments within 30 days prior to the surgery

          -  Subject has participated in another clinical study involving an investigational
             product (IP) or investigational device within 30 days prior to enrollment or is
             scheduled to participate in another clinical study involving an IP or investigational
             device during the course of this study

          -  Subject has a known sensitivity to fibrin sealants

          -  Subject is a friend, employee, or relative of the investigator or other study
             personnel