NCT01330433

Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Loma Linda University · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Congenital Heart Defect
• Surgery-Induced Tissue Adhesions
• Hemorrhage

Interventions

Type	Name	Description
DEVICE	CoSeal Surgical Spray Group	A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure. The dose regimen is as follows: * Patients weighing \< 3kg will receive 1ml of CoSeal * Patients weighing 3-10kg will receive 1-2ml of CoSeal * Patients weighing \>10kg will receive 2-4ml of CoSeal

Timeline

• Start date: 2011-08-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2011-04-07
• Last updated: 2016-12-15
• Results posted: 2016-08-25

Locations

1 site across 1 country: United States