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

University Hospital, Strasbourg, France

Status: Completed

Conditions: Antibiotic Prophylaxis

Study type: Observational

Funder types: Other

Identifiers

NCT05612542

7484

Details and patient eligibility

About

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

Enrollment: 400 patients

Sex: All

Ages: Under 17 years old

Volunteers: No 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