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

• Sponsor: University Hospital, Strasbourg, France (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05612542
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Anticipated Duration (Months): 38
• Patients Per Site Per Month: 10.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Antibiotic Prophylaxis

Study Design

• Study Type: Observational
• Anticipated Enrollment: 400 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Non-inferiority Study in Pediatric Cardiac Surgery Comparing Short 24-hour Antibiotic Prophylaxis to Extended Antibiotic Prophylaxis
• Actual Study Start Date: Nov 1, 2019
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Outcome Measures

Primary Outcome Measures

1. Number of postoperative care-related infections in cardiac surgery [24 hours after antibiotic prophylaxis]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service réanimation pédiatrique médico-chirurgicale spécialisée - CHU de Strasbourg - France	Strasbourg		France	67091

Sponsors and Collaborators

• University Hospital, Strasbourg, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Strasbourg, France
• ClinicalTrials.gov Identifier: NCT05612542
• Other Study ID Numbers: 7484
• First Posted: Nov 10, 2022
• Last Update Posted: Nov 10, 2022
• Last Verified: Nov 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Strasbourg, France: Antibiotic Prophylaxis; Bacterial proliferation; Bacterial infections; Postoperative infection; Pediatric cardiac surgery

Study Results

No Results Posted as of Nov 10, 2022