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

NCT05612542 | Completed

• 1 other identifier: 7484
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

Conditions

Antibiotic Prophylaxis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of postoperative care-related infections in cardiac surgery

  24 hours after antibiotic prophylaxis

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Minor patient, under 18 years of age, operated for cardiac surgery at the University Hospital of Strasbourg between January 2015 and June 2019, by sternal approach (sternotomy)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

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

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 10, 2022
• Study Start: September 2, 2019
• Primary Completion: February 2, 2020
• Study Completion: March 2, 2020
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

FR (1)