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

Antibiotic Prophylaxis Clinical Trial

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

Status Completed

Clinical Trial 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

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Antibiotic Prophylaxis

• NCT number: NCT05612542
• Study type: Observational
• Source: University Hospital, Strasbourg, France
• Status: Completed
• Start date: September 2, 2019
• Completion date: March 2, 2020