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

C

Children's Healthcare of Atlanta

Status

Completed

Conditions

Congenital Disorders

Treatments

Other: Observation of sternal reentry

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full description

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

Enrollment

802 patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

802 participants in 1 patient group

Observation of Sternal Re-entry
Description:
All subjects.
Treatment:
Other: Observation of sternal reentry

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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