A Pilot Study Evaluating the Efficacy and Safety of ARTISS Human Fibrin Sealant in External Rhinoplasty

Abstract

Background

Fibrin sealant application in rhytidectomy has previously demonstrated a reduction in adverse events and drainage volume. Fibrin sealant offers multiple potential benefits including decreasing downtime, reducing complication rates, and improving patient satisfaction. In this study, we evaluated the efficacy and safety of ARTISS [fibrin sealant (human)] in external rhinoplasty.

Methods

Nine healthy participants between the ages of 18 and 50 seeking external rhinoplasty completed this study. All subjects were randomized into control and treatment groups and then underwent external rhinoplasty, with only the treatment group receiving ARTISS [fibrin sealant (Human)] during surgery. Photographs were taken before surgery and 1 day, 1 week, 1 month, 3 months and 6 months after surgery and used in a blinded assessment of recovery time and esthetic improvement with ecchymosis and satisfaction scales. Subject recovery time, downtime, and self-esteem were evaluated at 1 day, 1 week, 1 month and 6 months after surgery. Recovery time was determined by live assessment of edema and ecchymosis using categorical scales. Subject downtime was assessed through a 30-day patient diary and a downtime questionnaire. Subject self-esteem was evaluated with the Heatherton & Polivy State Self-Esteem Scale. The degree of technical ease with the product was determined by the treating investigator with a 10-cm Visual Analog Scale.

Results

Patients treated with ARTISS intra-operatively reported significantly higher self-esteem 1 month and 6 months following external rhinoplasty. The ARTISS Easyspray™ Spray Set was rated as technically easy to administer.

Conclusion

The use of ARTISS fibrin sealant in external rhinoplasties is a safe and easy method and may enhance patient self-esteem. Larger studies are warranted to either verify or challenge the validity of our findings.

Level of Evidence IV

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