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

• Published in: Aesthetic surgery journal Vol. 33; no. 3; p. 323
• Main Authors: Hester, Jr, T Roderick, Gerut, Zachary E, Shire, James R, Nguyen, Davis B, Chen, Achih H, Diamond, Jason, Desmond, Julian C, Silvati-Fidell, Laura, Abrams, Steve Zvi
• Format: Journal Article
• Language: English
• Published: England 01.03.2013
• Subjects: Adult; Aged; Aging; Cross-Linking Reagents - adverse effects; Cross-Linking Reagents - therapeutic use; Drainage; Ecchymosis - etiology; Edema - etiology; Facial Pain - etiology; Female; Fibrin Tissue Adhesive - adverse effects; Fibrin Tissue Adhesive - therapeutic use; Hematoma - etiology; Hemostatics - adverse effects; Hemostatics - therapeutic use; Humans; Hypesthesia - etiology; Male; Middle Aged; Pain, Postoperative - etiology; Patient Satisfaction; Prospective Studies; Rejuvenation; Rhytidoplasty - adverse effects; Rhytidoplasty - methods; Rhytidoplasty - standards; Seroma - etiology; Skin Aging; Standard of Care; Time Factors; Treatment Outcome; United States; United States
• ISSN: 1527-330X
• DOI: 10.1177/1090820X13477860

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. 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. 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. 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. Adjuvant use of FS VH S/D 4 s-apr appears to be safe and results in lower drainage volumes than SoC treatment alone.