Abstract
Abstract
BAX602, a synthetic hydrogel composed of two polyethylene glycols, is an established anti-adhesive agent in adult cardiac surgery; however, clinical data regarding its safety and efficacy in the pediatric population remain scarce. This study aims to evaluate the efficacy and safety of BAX602 in reducing pericardial adhesions in pediatric patients undergoing staged surgery for congenital heart disease (CHD). This prospective, multicenter, randomized, controlled trial will be conducted across Japan. Thirty pediatric patients (
Clinical Trial: jRCT2032220540 (
https://jrct.niph.go.jp/latestdetail/jRCT2032220540
), NCT05647161 (
https://clinicaltrials.gov/study/NCT05647161#study-plan
).