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OpenTrials
Completed

NCT Number: NCT00328146

Re-operative Surgery in Children:A Technique for Sternal Re-Entry

Re-operative surgery in children is extremely challenging and injury to the underlying cardiac structures can occur during sternal re-entry. When institution of cardiopulmonary bypass is required in an emergency, there are often limited sites for peripheral cannulation. Injury to the heart can easily result in catastrophic complications and death.

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Key information

Conditions

Congenital Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

About this study

Background Re-operative surgery in children is extremely challenging and injury to the underlying cardiac structures can occur during sternal re-entry. When institution of cardiopulmonary bypass is required in an emergency, there are often limited sites for peripheral cannulation. Injury to the heart can easily result in catastrophic complications and death.

Methods This will be primarily a technique paper. The only clinical data points I am interested in are how many re-operative sternotomies we performed and on how many patients. I will also need to confirm that we did not have any complications due to cardiac injury while opening the sternum. I estimate about 450 patients.

Primary Aim: Present an effective technique for sternal re-entry in children

Secondary Aim: Present a zero incidence of complicated sternal re-entry over the past 5 years (February 1, 2001 through February 28, 2006) at Children's Healthcare of Atlanta, Egleston Hospital.

Inclusion / Exclusion Criteria Any child undergoing re-operative cardiac surgery through a midline sternotomy incision

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any child undergoing re-operative cardiac surgery through a midline sternotomy incision

Exclusion criteria

  • Those who do not fall under the above inclusion criteria

Treatment and study plan

Observation of sternal reentry

Other

Observation of sternal reentry

Primary outcomes

  1. Present an effective techniqe for sternal re-entry in children.

Sponsors and collaborators

Lead sponsor

Children's Healthcare of Atlanta

Other

Registry information

Official study title

Re-operative Surgery in Children: A Technique for Sternal Re-Entry

Important dates

Study start
2001
Primary completion
2009
Study completion
2009
First posted
May 19, 2006
Registry last updated
Mar 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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