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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05612542

Acronym

Prophylaxis

Enrollment

400

Registered

2022-11-10

Start date

2019-09-02

Completion date

2020-03-02

Last updated

2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic Prophylaxis

Keywords

Antibiotic Prophylaxis, Bacterial proliferation, Bacterial infections, Postoperative infection, Pediatric cardiac surgery

Brief summary

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

France

Outcome results