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

Antibiotic Prophylaxis Clinical Trial

— Prophylaxis  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05612542
• Other study ID #: 7484
• Status: Completed
• Start date: September 2, 2019
• Est. completion date: March 2, 2020

Study information

• Verified date: December 2023
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 2, 2020
• Est. primary completion date: February 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Prophylaxis

Locations

Country	Name	City	State
France	Service réanimation pédiatrique médico-chirurgicale spécialisée - CHU de Strasbourg - France	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of postoperative care-related infections in cardiac surgery		24 hours after antibiotic prophylaxis