Abstract
This is a prospective, randomized, active-controlled, single-blind, parallel group clinical trial to evaluate the safety and efficacy of FS Grifols as an adjunct to hemostasis during surgery in pediatric subjects. Pediatric subjects (<18 years of age) requiring an elective (non-emergent), open (non-laparoscopic), pelvic, abdominal, or thoracic (non-cardiac) surgical procedure, wherein a target bleeding site (tbs) is identified, and a topical hemostatic agent is indicated, will be eligible to participate in the clinical trial. the study treatments will be applied on the cut parenchymous surface of a solid organ (ie, liver) and in soft tissue (ie, fat, muscle, or connective tissue).>
