This is a prospective, randomized, open-label, blinded-evaluator study that will evaluate the effectiveness of a surgical sealant (CoSeal) composed of biocompatible polyethylene glycol on the formation of mediastinal and pericardial adhesions in children undergoing staged surgical reconstruction (potential procedures include: Blalock-Taussig Type Operation, Classical Glenn Procedure, Bidirectional Glenn Procedure, Norwood). Additionally, bleeding will be evaluated by drainage post-operatively through surgical site drainage output.
Age range
17 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Severity of Adhesions at the Retrosternal Site
Timeframe: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery
Severity of Adhesions at the Arterial Base Site.
Timeframe: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery
Severity of Adhesions at the Diaphragm Site
Timeframe: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery
Severity of Adhesions at the Left Lateral Site
Timeframe: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery
Severity of Adhesions at the Right Lateral Site
Timeframe: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery
Post-operative Bleeding
Timeframe: Post-operative bleeding data will be collected on average, during the first 36 hours after the surgery
Adhesion Burden
Timeframe: Time it takes for patient to be put on bypass (an average time between 0 and 120 minutes)