Investigational study of anti-adhetion effect of carboxymethyl cellulose sheet containing hyaluronic acid (Seprafilm) for pediatric cardiac surgery.

JRCT ID: jRCTs032180393

Registered date:20/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: congenital heart disease
• Date of first enrollment: 22/11/2019
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Put the carboxymethyl cellulose sheet containing hyaluronic acid (Seprafilm) to pericardiac lesion (heart, aorta, pulmonary artery, SVC, IVC) and infrasternal space before closing the chest.

Outcome(s)

• Primary Outcome: postoperative degree of adhesion
• Secondary Outcome: necessary time for dissecting the adhesion at the next operation

Key inclusion & exclusion criteria

• Age minimum: >=
• Age maximum: < 6age old
• Gender: Both
• Include criteria: patient who underwent (1) cardiac palliative procedure via median sternotomy or (2) Glenn procedure or other cardiac palliative procedure in advance of Fontan procedure.

Exclude criteria

1. preoperative hemodynamic state is fragile
2. MRSA positive
3. difficult to sternal closure

Related Information

• Primary Sponsor: Yoshimura Yukihiro