Clinician reported ease of use for a novel fibrin sealant patch for hemostasis: results from four randomized controlled trials
| Autor: | A. Hogan, J. Shen, Mitra Corral, S. Hollmann, Nicole Ferko, Jonathan Batiller, N. Jamous |
|---|---|
| Rok vydání: | 2015 |
| Předmět: |
medicine.medical_specialty
Standard of care Blood Loss Surgical Transdermal Patch Fibrin Tissue Adhesive 030204 cardiovascular system & hematology Hemostatics Fibrin law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Surveys and Questionnaires medicine Humans Randomized Controlled Trials as Topic Hemostasis biology business.industry Sealant Soft tissue Usability General Medicine Surgery 030220 oncology & carcinogenesis biology.protein business |
| Zdroj: | Current Medical Research and Opinion. 32:367-375 |
| ISSN: | 1473-4877 0300-7995 0065-8723 |
| Popis: | In addition to rapid and sustained efficacy, ease of use is also an important characteristic of topical hemostats.To evaluate clinician-reported ease of use for the Evarrest fibrin sealant patch across various surgical bleeding situations.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.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.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. |
| Databáze: | OpenAIRE |
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