Abstract / Summary
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 (< 12 years old) undergoing their initial staged cardiac surgery via midline sternotomy and pericardiotomy will be randomized (1:1) to either the BAX602 application group or the untreated control group. Based on real-world trends from the Japan Cardiovascular Surgery Database, the interval between the first- and second-stage operations is expected to be 3–12 months. The primary endpoint is the severity of adhesions at the second surgery, quantified across six prespecified anatomical sites: the pericardiotomy edge, right ventricular anterior and diaphragmatic surfaces, right atrial body and appendage, and the ascending aorta. Adhesion severity will be evaluated using a standardized 5-grade scale ranging from 0 (no adhesions) to 4 (dense/cohesive adhesions requiring extensive sharp dissection). This protocol is designed to provide robust clinical evidence supporting the efficacy and safety of BAX602, potentially facilitating its regulatory approval and clinical integration into pediatric cardiac surgery. This trial will clarify the role of BAX602 in mitigating surgical adhesions, potentially improving safety and procedural outcomes for pediatric patients requiring multiple cardiac interventions. Clinical Trial: jRCT2032220540 ( https://jrct.niph.go.jp/latestdetail/jRCT2032220540 ), NCT05647161 ( https://clinicaltrials.gov/study/NCT05647161#study-plan ).