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

Congenital Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00328146
• Other study ID #: 06-105
• Status: Completed
• Phase: N/A
• First received: May 18, 2006
• Last updated: February 27, 2017
• Start date: February 2001
• Est. completion date: October 2009

Study information

• Verified date: February 2017
• Source: Children's Healthcare of Atlanta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 802
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Disorders

Intervention

Other:
• Observation of sternal reentry
Observation of sternal reentry

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Children's Healthcare of Atlanta

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Present an effective techniqe for sternal re-entry in children.