BAX602 in Preventing the Adhesion Around Great Cardiac Vessels in Pediatric Patients With Congenital Heart Disease Undergoing Re-do Open Heart Surgery (Japan Trial)

NAActive, not recruitingINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

December 8, 2022

Primary Completion Date

October 31, 2025

Study Completion Date

December 31, 2025

Conditions
Congenital Heart Disease in Children
Interventions
DEVICE

BAX602

Consists of the spray agent, spray set, and spraying device (regulator). Dissolves a polyethylene glycol (PEG) derivative with an N-hydroxysuccinimide group at the end (COH102) and a PEG derivative with a thiol group (COH206) as an anti-adhesion agent, which is sprayed on the surgical surface to reduce the degree, frequency, and extent of organ adhesions after surgery.

DEVICE

No Intervention

Control Group

Trial Locations (6)

3998288

Nagano Children's Hospital, Azumino

6500047

Hyogo Prefectural Kobe Children's Hospital, Kobe

474-8710

Aichi Children's Hospital and Medical Center, Ōbu

813-0017

Fukuoka Children's Hospital, Fukuoka

700-8558

Okayama University Hospital, Okayama

420-8660

Shizuoka Children's Hospital, Shizuoka

All Listed Sponsors
lead

Baxter Healthcare Corporation

INDUSTRY

NCT05647161 - BAX602 in Preventing the Adhesion Around Great Cardiac Vessels in Pediatric Patients With Congenital Heart Disease Undergoing Re-do Open Heart Surgery (Japan Trial) | Biotech Hunter | Biotech Hunter