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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05612542
Other study ID # 7484
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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