title: 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.
abstract: BACKGROUND
  Suction drains are commonly placed after rhytidectomy surgery to avoid seroma formation that may result from dead spaces between skin layers. Fibrin sealants promote tissue adherence by cross-linking with extracellular matrix proteins, which may reduce the dead space under skin flaps.
  
  
  OBJECTIVE
  The authors evaluate the safety and preliminary efficacy of the fibrin sealant (FS) VH S/D 4 s-apr (ARTISS; Baxter Healthcare Corp, Deerfield, Illinois), added to standard-of-care (SoC) treatment, on tissue plane adherence and local hemostasis in rhytidectomy patients.
  
  
  METHODS
  In this phase 2, prospective, controlled, randomized, evaluator- and patient-blinded, multicenter study, 45 patients (of 56 possible enrollees) received SoC treatment on 1 side of the face and adjunctive FS VH S/D 4 s-apr treatment on the other side. Outcomes measures included visual assessments of ecchymosis (by blinded reviewers), grading of ecchymosis and edema, drainage volumes, occurrence of hematoma/seroma, safety evaluations, and patient-reported assessments of pain, numbness, and treatment preferences postoperatively.
  
  
  RESULTS
  Mean patient age was 55.1 years. Rates and grades of ecchymosis and edema were similar for the 2 treatments. The mean (SD) drainage volume 24 hours after surgery was 11.5 (13.7) mL from the FS VH S/D 4 s-apr-treated sides of the face and 26.8 (24.0) mL from the SoC-only sides (P < .0001). Patient assessments of pain, numbness, and preference favored treatment with FS VH S/D 4 s-apr. Adverse events were mild to moderate in severity.
  
  
  CONCLUSIONS
  Adjuvant use of FS VH S/D 4 s-apr appears to be safe and results in lower drainage volumes than SoC treatment alone.
authors.affiliation: Private practice in Atlanta, Georgia, USA.
authors.forename: T Roderick
authors.initials: TR
authors.lastname: Hester
authors.forename: Zachary E
authors.initials: ZE
authors.lastname: Gerut
authors.forename: James R
authors.initials: JR
authors.lastname: Shire
authors.forename: Davis B
authors.initials: DB
authors.lastname: Nguyen
authors.forename: Achih H
authors.initials: AH
authors.lastname: Chen
authors.forename: Jason
authors.initials: J
authors.lastname: Diamond
authors.forename: Julian C
authors.initials: JC
authors.lastname: Desmond
authors.forename: Laura
authors.initials: L
authors.lastname: Silvati-Fidell
authors.forename: Steve Zvi
authors.initials: SZ
authors.lastname: Abrams
mesh_terms: D000328:Adult; D000368:Aged; D000375:Aging; D003432:Cross-Linking Reagents / Q000009:adverse effects / Q000627:therapeutic use*; D004322:Drainage; D004438:Ecchymosis / Q000209:etiology; D004487:Edema / Q000209:etiology; D005157:Facial Pain / Q000209:etiology; D005260:Female; D015718:Fibrin Tissue Adhesive / Q000009:adverse effects / Q000627:therapeutic use*; D006406:Hematoma / Q000209:etiology; D006490:Hemostatics / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D006987:Hypesthesia / Q000209:etiology; D008297:Male; D008875:Middle Aged; D010149:Postoperative Pain / Q000209:etiology; D017060:Patient Satisfaction; D011446:Prospective Studies; D012060:Rejuvenation; D015361:Rhytidoplasty / Q000009:adverse effects / Q000379:methods* / Q000592:standards; D049291:Seroma / Q000209:etiology; D015595:Skin Aging; D059039:Standard of Care; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D003432:Cross-Linking Reagents; D015718:Fibrin Tissue Adhesive; D006490:Hemostatics