Congenital heart disease occurs in about 1% of live births and can range from (1) naturally curable conditions that require no treatment to (2) conditions that require multiple immediate operations or refractory severe conditions. In the course of a staged surgical intervention, adhesion formation around the heart and large vessels can occur, and dissection of the adhesion site is required at the time of reoperation. There is a concern that dissection may markedly increase the risk of operation such as prolonged surgical time, cardiovascular injury, and increased blood loss, and medical devices to prevent adhesion formation after operation in the field of pediatric cardiovascular operation are strongly desired in medical settings. The investigational product (BAX602), which has already been manufactured and marketed by Baxter overseas, has been used for open heart surgery as a local hemostatic agent without biological materials in Europe and the US for more than 20 years. However, since it has not been approved in Japan, this randomized controlled study will be conducted in Japan to demonstrate the effect of BAX602 to prevent and reduce adhesion formation between the surface of the heart/large vessels and surrounding tissues in pediatric patients undergoing planned multistage operation for congenital heart disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
34
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.
Control Group
Aichi Children's Hospital and Medical Center
Ōbu, Aichi-ken, Japan
Fukuoka Children's Hospital
Fukuoka, Fukuoka, Japan
Hyogo Prefectural Kobe Children's Hospital
Kobe, Hyōgo, Japan
Nagano Children's Hospital
Azumino, Nagano, Japan
Okayama University Hospital
Okayama, Okayama-ken, Japan
Shizuoka Children's Hospital
Shizuoka, Shizuoka, Japan
Grade of adhesion between the surface of the heart/large vessels and surrounding tissues
The following score of adhesion grade will be used: Grade 0=No adhesions; Grade 1=Filmy and avascular; Grade 3=Filmy, noncohesive requiring blunt and sharp dissection; Grade 4=Dense and cohesive requiring extensive sharp dissection. Lower score is better outcome.
Time frame: Day 90 to Day 360 (2nd open heart surgery)
Total surgery time
Time frame: Day 90 to Day 360 (2nd open heart surgery)
Time from start of skin incision to start of extracorporeal circulation
Time frame: Day 90 to Day 360 (2nd open heart surgery)
Time from start of skin incision to the end of adhesion dissection
Time frame: Day 90 to Day 360 (2nd open heart surgery)
Total score of grade of adhesion at evaluation sites
The following score of adhesion grade will be used: Grade 0=No adhesions; Grade 1=Filmy and avascular; Grade 3=Filmy, noncohesive requiring blunt and sharp dissection; Grade 4=Dense and cohesive requiring extensive sharp dissection. Lower score is better outcome. Adhesion will be evaluated at the following six sites. 1. Pericardiotomy incision line area 2. Anterior surface of the right ventricle 3. Ascending aorta area 4. Right atrial appendage 5. Right atrial body 6. Diaphragmatic surface
Time frame: Day 90 to Day 360 (2nd open heart surgery)
Grade of adhesion by evaluation site and presence or absence of extracorporeal circulation
Time frame: Day 90 to Day 360 (2nd open heart surgery)
Number of sites of Grades ≥1, ≥2, ≥3, or 4 of adhesion
Time frame: Day 90 to Day 360 (2nd open heart surgery)
Number of participants with sites of Grades ≥1, ≥2, ≥3, or 4 of adhesion
Time frame: Day 90 to Day 360 (2nd open heart surgery)
Worst grade of adhesion by participants
Time frame: Day 90 to Day 360 (2nd open heart surgery)
Intraoperative breeding amount
Time frame: Day 90 to Day 360 (2nd open heart surgery)
Number of participants by type of local hemostatic agent used during surgery
Time frame: Day 90 to Day 360 (2nd open heart surgery)
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