Clinician reported ease of use for a novel fibrin sealant patch for hemostasis: results from four randomized controlled trials

Abstract

Background:

In addition to rapid and sustained efficacy, ease of use is also an important characteristic of topical hemostats.

Objectives:

To evaluate clinician-reported ease of use for the Evarrest fibrin sealant patch across various surgical bleeding situations.

Methods:

An ease of use questionnaire (EUQ) was validated and administered in four randomized studies comparing the fibrin sealant patch to standard of care (SoC) in soft tissue and hepatic surgical bleeding. Three of these randomized studies have been previously published and all have been registered (NCT00658723; NCT00977925; NCT01166243; NCT01993888). The EUQ is a 19 item instrument evaluating clinician’s preferences on five subscales: product ease of use, satisfaction with product properties and efficiency, confidence in product efficacy, global confidence, and global satisfaction. A pair-wise meta-analysis using a random effects model was conducted on EUQ scores for trials that reported data for both treatment arms. Individual scores are presented for each trial.

Results:

The fibrin sealant patch demonstrated numerically greater scores than SoC in all EUQ subscales. The meta-analysis demonstrated that fibrin sealant patch scores improved for all subscales compared with SoC: satisfaction with product properties (mean difference [MD] = 0.38, 95% CI: 0.04 to 0.73; P = 0.03), confidence in efficacy (MD = 1.10, 95% CI: 0.47 to 1.74; P = 0.0007), global confidence (MD = 0.57, 95% CI: 0.05 to 1.10, P = 0.03), global satisfaction (MD = 0.79, 95% CI: 0.32 to 1.26, P = 0.001), and ease of use (MD = 0.33, 95% CI: -0.29 to 0.94; P = 0.23). Fibrin sealant patch single arm trial results aligned with these findings.

Conclusions:

Physicians consistently reported high EUQ scores for the fibrin sealant patch across surgical bleeding populations. An important limitation of this study was that the composition of SoC varied across studies and EUQ data were only available for the SoC in two of four trials. Future studies should evaluate ease of use for other hemostats and across other surgical subspecialties, as data are currently limited.

Keywords: :

• Bleeding
• Fibrin sealant
• Hemostatics
• Questionnaire
• Surgery

Transparency

Declaration of funding

This study was funded by Ethicon Inc.

Author contributions: M. Corral, J. Batiller, N. Jamous, and J. Shen: Involved in design, analysis, revising intellectual content of manuscript and final approval. N. Ferko, A. Hogan, and S. Hollmann: Involved in the design, analyses, interpretation of results, manuscript development and final approval.

Declaration of financial/other relationships

N.F., A.H., and S.H. have disclosed that they received funding from Ethicon Inc. to conduct this study and prepare the manuscript. M.C., N.J., J.B., and J.S. have disclosed that they were employees of Ethicon Inc. at the time of manuscript development.

CMRO peer reviewer 1 has disclosed that he is a consultant to Ethicon. Peer reviewer 2 has no relevant financial or other relationships to disclose.

Acknowledgments

The authors of this work would like to thank Marcia Rupnow PhD for her contribution in the development of the ease of use questionnaire.

Previous presentation: This work was also presented at the 60th Scientific and Standardization Committee meeting of the International Society on Thrombosis and Haemostasis, Milwaukee, WI, USA, 23–26 June 2014.

Notes

*Evarrest is a registered trade name of Ethicon Inc.

*Evarrest is a registered trade name of Johnson & Johnson (New Brunswick, NJ, USA)

†Surgicel is a registered trade name of Johnson & Johnson (New Brunswick, NJ, USA)

*Evicel is a registered trade name of Johnson & Johnson (New Brunswick, NJ, USA)

†Tisseel is a registered trade name of Baxter International (Deerfield, IL, USA)