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

Completed
Conditions
Antibiotic Prophylaxis
Registration Number
NCT05612542
Lead Sponsor
University Hospital, Strasbourg, France
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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
400
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Number of postoperative care-related infections in cardiac surgery24 hours after antibiotic prophylaxis
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

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

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Strasbourg, France

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