title: Randomized, controlled, phase 3 study to evaluate the safety and efficacy of fibrin sealant VH S/D 4 s-apr (Artiss) to improve tissue adherence in subjects undergoing rhytidectomy.
abstract: BACKGROUND
  Suction drains are commonly placed after rhytidectomy to avoid seroma formation that may result from dead spaces between skin layers. Fibrin sealants promote tissue adherence by crosslinking with extracellular matrix proteins, which may reduce the dead space under skin flaps.
  
  
  OBJECTIVE
  The authors evaluate the safety and 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, in improving flap adherence and reducing dead space in patients undergoing rhytidectomy.
  
  
  METHODS
  Patients with planned facial rhytidectomy were enrolled in this phase 3, prospective, controlled, randomized, patient-blinded, multicenter trial. They received SoC treatment on 1 side of the face and adjunctive FS VH S/D 4 s-apr on the other.
  
  
  RESULTS
  Seventy-five patients completed the trial. The mean (SD) drainage volume was 7.7 (7.4) mL from the sides treated with sealant and 20.0 (11.3) mL from the SoC-only sides (P < .0001). Rates of hematoma and seroma were similar for the 2 treatments, as were changes in postoperative skin sensitivity. Adverse events generally were mild; 2 serious adverse events were reported (wound abscess, dehydration).
  
  
  CONCLUSIONS
  Adjunct use of FS VH S/D 4 s-apr in rhytidectomy was proven safe in this study. It significantly reduced drainage volumes without increasing the incidence of hematoma or seroma, which suggests that it eliminates dead space through improved flap adherence.
  
  
  METHODS
  2.
authors.affiliation: Baxter Healthcare Corporation, One Baxter Way, Westlake Village, CA 91362-3811 USA.
authors.forename: T Roderick
authors.initials: TR
authors.lastname: Hester
authors.forename: James R
authors.initials: JR
authors.lastname: Shire
authors.forename: Davis B
authors.initials: DB
authors.lastname: Nguyen
authors.forename: Zachary E
authors.initials: ZE
authors.lastname: Gerut
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
authors.forename: Rod J
authors.initials: RJ
authors.lastname: Rohrich
mesh_terms: D000328:Adult; D000368:Aged; D004322:Drainage / Q000009:adverse effects / Q000379:methods; D005260:Female; D015718:Fibrin Tissue Adhesive / Q000627:therapeutic use*; D006406:Hematoma / Q000517:prevention & control; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000517:prevention & control; D011446:Prospective Studies; D015361:Rhytidoplasty / Q000009:adverse effects / Q000379:methods*; D049291:Seroma / Q000517:prevention & control; D016037:Single-Blind Method; D015595:Skin Aging / Q000502:physiology; D013524:Surgical Flaps / Q000098:blood supply*; D013718:Tensile Strength; D014014:Tissue Adhesives / Q000627:therapeutic use; D014945:Wound Healing / Q000187:drug effects* / Q000502:physiology
chemical_list: D015718:Fibrin Tissue Adhesive; D014014:Tissue Adhesives
keywords: facial surgery; fibrin sealant; rhytidectomy; tissue adherence