Status:

COMPLETED

Surgical Site Infection Study

Lead Sponsor:

Children's Hospital of Philadelphia

Conditions:

Cava-pulmonary Anastomosis

Eligibility:

All Genders

3-6 years

Brief Summary

The purpose of this study is to investigate the pharmacokinetics of cefazolin using both plasma and microdialysate sampling methods in children with single ventricle physiology undergoing their second...

Detailed Description

This study aims to sample interstitial fluid (IF) of infants undergoing superior cava-pulmonary anastomosis (either Glenn or Hemi-Fontan) cardiac surgical procedures who receive cefazolin as their sur...

Eligibility Criteria

Inclusion

  • Males or females with single ventricle physiology undergoing their second palliation procedure (typically performed between 3-6 months of age)
  • Use of cefazolin as the prophylactic antibiotic during the operation
  • Written informed consent provided by the parent or legal guardian

Exclusion

  • Use of prophylactic antibiotic other than cefazolin during the operation
  • Anatomic or other abnormalities of the upper arm that would preclude insertion of a microdialysis catheter
  • Known renal or hepatic function

Key Trial Info

Start Date :

September 1 2011

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

February 1 2014

Estimated Enrollment :

14 Patients enrolled

Trial Details

Trial ID

NCT01449669

Start Date

September 1 2011

End Date

February 1 2014

Last Update

February 10 2014

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