title: 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.
  
  
  OBJECTIVE
  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.
authors.affiliation: a a Ethicon Inc. , Somerville , NJ , United States.
authors.forename: M
authors.initials: M
authors.lastname: Corral
authors.affiliation: b b Cornerstone Research Group , Burlington , ON , Canada.
authors.forename: N
authors.initials: N
authors.lastname: Ferko
authors.affiliation: b b Cornerstone Research Group , Burlington , ON , Canada.
authors.forename: S
authors.initials: S
authors.lastname: Hollmann
authors.affiliation: b b Cornerstone Research Group , Burlington , ON , Canada.
authors.forename: A
authors.initials: A
authors.lastname: Hogan
authors.affiliation: c c Ethicon Inc. , Berkshire , United Kingdom.
authors.forename: N
authors.initials: N
authors.lastname: Jamous
authors.affiliation: a a Ethicon Inc. , Somerville , NJ , United States.
authors.forename: J
authors.initials: J
authors.lastname: Batiller
authors.affiliation: a a Ethicon Inc. , Somerville , NJ , United States.
authors.forename: J
authors.initials: J
authors.lastname: Shen
mesh_terms: D016063:Blood Loss, Surgical / Q000517:prevention & control*; D015718:Fibrin Tissue Adhesive / Q000008:administration & dosage*; D006487:Hemostasis; D006490:Hemostatics / Q000008:administration & dosage*; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D011795:Surveys and Questionnaires; D057968:Transdermal Patch
chemical_list: D015718:Fibrin Tissue Adhesive; D006490:Hemostatics
keywords: Bleeding; Fibrin sealant; Hemostatics; Questionnaire; Surgery