Skip to main content
OpenTrials
Completed

NCT Number: NCT05612542

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Antibiotic Prophylaxis Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Service réanimation pédiatrique médico-chirurgicale spécialisée - CHU de Strasbourg - France

Strasbourg, 67091, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of postoperative care-related infections in cardiac surgery

    Time frame: 24 hours after antibiotic prophylaxis

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: Prophylaxis

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 10, 2022
Registry last updated
Dec 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.