Management of Persistent Epistaxis Using Floseal Hemostatic Matrix vs. traditional nasal packing: a prospective randomized control trial

Abstract

Background: Epistaxis is the most common emergent consultation to otolaryngology-head & neck surgery (OHNS) and with 60% of the population having experienced an episode and 1.6 in 10,000 requiring hospitalization in their lifetime. In preliminary studies Floseal® (Baxter, USA) Hemostatic Matrix has shown efficacy in up to 80% of persistent anterior epistaxis. We sought to evaluate the clinical efficacy and cost-effectiveness of Floseal® (Baxter, USA) compared to traditional nasal packing for persistent epistaxis.

Methods: A prospective, randomized controlled trial was conducted on all adult patients consulted to the OHNS service at the tertiary referral centers of the University of Alberta Hospital and Royal Alexandra Hospital for persistent epistaxis. Patients were randomized to the Floseal® (Baxter, USA) or traditional packing study arms. Our main clinical outcome measures were: 1) Hemostasis directly following treatment and at 48 h post-treatment, and 2) self-reported patient comfort at 48 h post-treatment. Further, trial data was used for a formal cost-effectiveness analysis to determine incremental cost-effectiveness ratio (ICER). Univariate sensitivity analysis and uncertainty analysis were performed.

Results: There were no significant differences between groups for initial hemostasis (76.9% vs. 84.6%, p = 1.000) or, hemostasis at 48 h (76.9% vs. 69.2%, p = 1.000), requirement for admission (15.4% vs. 46.1%, p = 0.2016) or 30-day re-presentation rates (15.4% vs. 46.1%, p = 0.2016). Floseal® (Baxter, USA) was superior for decreased pain during placement (2.42 vs. 7.77, p = 0.0022), treatment (0.50 vs. 4.46, p = 0.0007) and removal (0 vs. 3.85, p = 0.0021). Floseal® (Baxter, USA) provides an average $1567.61 per patient savings from the single-payer system point of view and has an ICER of - $11,891 per re-bleed prevented (95% CI: -$37,658 to +$473). Uncertainty analysis shows that Floseal® has >90% chance of not only being cost-effective, but the dominant (preferred) treatment.

Conclusions: Floseal® (Baxter, USA) was demonstrated to be an effective, comfortable and cost-effective alternative treatment of persistent epistaxis when compared to traditional packing methods for patients referred to OHNS with a normal coagulation profile.

Trial registration: Trial registration number: NCT02488135 . Date registered: June 26, 2015.

Keywords: Epistaxis; Floseal® (Baxter; Nasal packing; Persistent; USA).

Conflict of interest statement

Ethics approval and consent to participate

The Health and Research Ethics Board of the University of Alberta approved this study (REB#: Pro00057060). Written consent was attained from all study participants prior to treatment.

Consent for publication

Not applicable.

Competing interests

To all of the authors’ knowledge this manuscript adheres to the Journal of Otolaryngology-Head & Neck Surgery’s editorial policies. Possible perceived competing interests include receiving an unrestricted research grant of Floseal® (Baxter, USA) product from Baxter.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1

Patient flow diagram participant numbers for enrollment, allocation, follow-up and analysis

Fig. 2

Cost effectiveness acceptability curve for Floseal® (Baxter, USA) Hemostatic Matrix

Fig. 3

95% Confidence ellipses of bootstrapped incremental costs and incremental effects from both health system and societal perspectives (cost-effectiveness plane). Legend: *point estimate residing in the right lower quadrant indicates that the treatment (i.e. Floseal® (Baxter, USA)) is by definition, cost-effective and dominant)