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Type of Material in Repair of Congenital Diaphragmatic Hernia

NCT00257946 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-12-15

No results posted yet for this study

Summary

The objective of this study is to evaluate the use of 2 different types of biosynthetic material for the repair of congenital diaphragmatic hernia. The research question is: what is the best material for repairing large congenital diaphragmatic hernias? The primary outcome variable is recurrence.

Conditions

  • Congenital Diaphragmatic Hernia

Interventions

PROCEDURE

Repair of CDH w/SIS Gold

PROCEDURE

Repair of CDH w/Alloderm

Sponsors & Collaborators

  • Children's Mercy Hospital Kansas City

    lead OTHER

Principal Investigators

  • Shawn D St. Peter, MD · Children's Mercy Hospital Kansas City

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
2 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2007-08-31
Completion
2007-08-31

Countries

  • United States

Study Locations

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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 NCT00257946 on ClinicalTrials.gov