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

T. Roderick Hester, Zachary E. Gerut, James R. Shire, Davis B. Nguyen, Achih H. Chen, Jason Diamond, Julian C. Desmond, Laura Silvati-Fidell, Steve Zvi Abrams

Research output: Contribution to journalArticle

12 Scopus citations

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. Objectives: 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.

Original languageEnglish (US)
Pages (from-to)323-333
Number of pages11
JournalAesthetic Surgery Journal
Volume33
Issue number3
DOIs
StatePublished - Mar 1 2013

Keywords

  • fibrin sealant
  • hemostasis
  • rhytidectomy
  • tissue adherence

ASJC Scopus subject areas

  • Surgery

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    Hester, T. R., Gerut, Z. E., Shire, J. R., Nguyen, D. B., Chen, A. H., Diamond, J., Desmond, J. C., Silvati-Fidell, L., & Abrams, S. Z. (2013). 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. Aesthetic Surgery Journal, 33(3), 323-333. https://doi.org/10.1177/1090820X13477860