Pediatric Cardiac Surgery Comparing Short 24-hour Antibiotic Prophylaxis to Extended Antibiotic Prophylaxis (Prophylaxis)

Non-inferiority Study in Pediatric Cardiac Surgery Comparing Short 24-hour Antibiotic Prophylaxis to Extended Antibiotic Prophylaxis

The objective of antibiotic prophylaxis is to prevent bacterial proliferation in order to reduce the risk of postoperative infection.

Numerous recent recommendations show a benefit of a reduced duration of antibiotic prophylaxis in surgery, particularly in pediatrics.

The study focuses on the incidence of postoperative infection by comparing antibiotic prophylaxis with 2nd generation cephalosporin (G2G) for 48 hours to a short antibiotic prophylaxis protocol limited to 24 hours.

The bacterial infections considered were those said to be care-related, according to the criteria of the French Society of Anesthesia and Intensive Care if they occurred within the 3 months postoperative interval and were not present before the surgery:

• sepsis
• superficial or deep surgical site infection (mediastinitis, sternitis, scar infection)
• catheterization infection,
• urinary tract infection or
• respiratory infection such as pneumopathy acquired under mechanical ventilation

The hypothesis is that reducing the duration of antibiotic prophylaxis does not expose patients to an increased risk of infection and limits exposure to antibiotics

Study Overview

• Status: Completed
• Conditions: Antibiotic Prophylaxis

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67091
    • Service réanimation pédiatrique médico-chirurgicale spécialisée - CHU de Strasbourg - France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 13 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Minor patient, under 18 years of age, operated for cardiac surgery at the University Hospital of Strasbourg between January 2015 and June 2019, by sternal approach (sternotomy)

Description

Inclusion criteria:

• Child less than 18 years of age,
• Operated for cardiac surgery at the University Hospital of Strasbourg between January 2015 and June 2019, by sternal approach (sternotomy),
• Child and holders of parental authority who have not expressed, after information, their objections to the reuse of his for the purpose of this research.

Exclusion criteria:

• Child who has undergone thoracic heart surgery (thoracotomy),
• Child with an infection at the time of heart surgery,
• Child and parental authority holders who have expressed their objections to participating in this research

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of postoperative care-related infections in cardiac surgery	24 hours after antibiotic prophylaxis

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2019
• Primary Completion (Actual): February 2, 2020
• Study Completion (Actual): March 2, 2020

Study Registration Dates

• First Submitted: November 3, 2022
• First Submitted That Met QC Criteria: November 3, 2022
• First Posted (Actual): November 10, 2022

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Bacterial infections; Antibiotic Prophylaxis; Postoperative infection; Bacterial proliferation; Pediatric cardiac surgery
• Other Study ID Numbers: 7484

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No