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Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery

NCT01330433 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2016-12-15

Study results available
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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

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

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Loma Linda University

    lead OTHER

Principal Investigators

  • Nahidh Hasaniya, MD · Loma Linda University Medical Center

  • Anees Razzouk, MD · Loma Linda University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01330433 on ClinicalTrials.gov