CClinicalTrials.gg
CompletedNCT00328146Updated Mar 1, 2017

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

An observational study in Congenital Disorders, sponsored by Children's Healthcare of Atlanta. Completed at 1 site in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2017-03-01.

Sponsored by Children's Healthcare of Atlanta · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
802
Ages
Up to 18 Years
Sex
All
01

Study summary

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.

Read the detailed 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

02

Conditions studied

  • Congenital Disorders

Keywords

  • pediatric
  • cardiac
  • re-operative surgery
03

In context

Lead sponsor

Children's Healthcare of Atlanta is the lead sponsor of 95 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Any child undergoing re-operative cardiac surgery through a midline sternotomy incision. This is a chart review.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Those who do not fall under the above inclusion criteria
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
802 participants (actual)
Patient registry
No

Groups and cohorts

  • Observation of Sternal Re-entry

    All subjects.

    Other: Observation of sternal reentry

Interventions

  • OtherObservation of sternal reentry

    Observation of sternal reentry

06

What researchers measure

Primary outcomes

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

07

Study locations

1 site
  • Children's Healthcare of Atlanta
    Atlanta, Georgia 30322, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00328146
Lead sponsor
Children's Healthcare of Atlanta
Responsible party
Sponsor
First posted
May 19, 2006
Start date
Feb 2001
Primary completion
Oct 2009
Completion
Oct 2009
Last update
Mar 1, 2017

Study contacts

Brian E Kogon, MD
principal investigator · Children's Healthcare of Atlanta

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion