Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery

Effects of CoSeal in Reducing Perioperative Bleeding & Adhesions in Pediatric Heart Surgery

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.

Inclusion Criteria:

• Have an acceptable surrogate capable of giving consent on the subject's behalf.
• Pediatric patients ages 0 - 17
• Have a cardiac disease which requires staged cardiac surgery and resternotomy
• Non-emergent state or emergent state with sufficient time to educate and consent

Exclusion Criteria:

• An immune system disorder
• Unplanned reoperation
• Known hypersensitivity to components in CoSeal
• Patients undergoing reoperation less than 3 months after the primary surgery