A Study of Safety and Effectiveness of Evicel Fibrin Sealant as an Adjunctive Hemostat in Pediatric Surgery
Topic overview
Phase III randomized trial comparing Evicel fibrin sealant to Surgicel for controlling mild-to-moderate surgical bleeding in 40 pediatric patients aged 0.9-17 years. Evicel demonstrated comparable time-to-hemostasis (4 minutes median) with lower treatment failure rates (5% vs 25%) and no thromboembolic events, supporting its safety and efficacy across various pediatric surgical procedures.
Key takeaways
- Evicel fibrin sealant demonstrated 80% hemostasis success at 4 minutes versus 65% for Surgicel in pediatric surgery patients aged 0.9-17 years.
- Treatment failure rates were significantly lower with Evicel (5%) compared to Surgicel (25%) for mild-to-moderate intraoperative bleeding.
- No thromboembolic events or deaths occurred in either group, supporting the safety profile of Evicel in pediatric surgical populations.
- Evicel achieved hemostasis despite treating larger median bleeding areas (4.0 cm² vs 1.0 cm²) compared to Surgicel control.
- Phase III trial supports Evicel as an effective adjunctive hemostat across diverse pediatric abdominal, thoracic, and pelvic procedures.
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How to cite: GlobalCastMD. A Study of Safety and Effectiveness of Evicel Fibrin Sealant as an Adjunctive Hemostat in Pediatric Surgery. GlobalCastMD Medical Library. 2024-03-29. https://dev.library.globalcastmd.com/article/8410?via_space=staycurrentmd
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