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.

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.

• Authors: T Roderick Hester Jr, Zachary E Gerut, James R Shire, Davis B Nguyen, Achih H Chen, Jason Diamond, Julian C Desmond, Laura Silvati-Fidell, Steve Zvi Abrams
• Journal: Aesthetic surgery journal (Aesthet Surg J) Vol. 33 Issue 3 Pg. 323-33 (Mar 2013) ISSN: 1527-330X [Electronic] England
• PMID: 23515377 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Cross-Linking Reagents
• Fibrin Tissue Adhesive
• Hemostatics

Topics

• Adult
• Aged
• Aging
• Cross-Linking Reagents (adverse effects, therapeutic use)
• Drainage
• Ecchymosis (etiology)
• Edema (etiology)
• Facial Pain (etiology)
• Female
• Fibrin Tissue Adhesive (adverse effects, therapeutic use)
• Hematoma (etiology)
• Hemostatics (adverse effects, therapeutic use)
• Humans
• Hypesthesia (etiology)
• Male
• Middle Aged
• Pain, Postoperative (etiology)
• Patient Satisfaction
• Prospective Studies
• Rejuvenation
• Rhytidoplasty (adverse effects, methods, standards)
• Seroma (etiology)
• Skin Aging
• Standard of Care
• Time Factors
• Treatment Outcome
• United States