NCT05612542

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
• Phase: —
• Study type: Observational
• Enrollment: 400 (actual)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: All
• Age: 0 Years – 17 Years
• Healthy volunteers: Not accepted

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

Conditions

• Antibiotic Prophylaxis

Timeline

• Start date: 2019-09-02
• Primary completion: 2020-02-02
• Completion: 2020-03-02
• First posted: 2022-11-10
• Last updated: 2023-12-19

Locations

1 site across 1 country: France