Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery

Completed · Phase 2

Conditions studied: Congenital Heart Defect, Surgery-Induced Tissue Adhesions, Hemorrhage

In brief

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.

Key facts

Study ID

NCT01330433

Run by

Loma Linda University

People needed

35

Starts

2011-08-01

Expected to finish

2015-08-01

Last updated by the study team

2016-12-15

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Loma Linda University Medical Center — Loma Linda, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.