Post-operative Antibiotics; Effects on Risk of Infection After Cochlear Implant Surgery

Active, not recruiting

• Conditions: Postoperative Infection
• Interventions: Drug: Antibiotic

• Registration Number: NCT06177444
• Lead Sponsor: Odense University Hospital

Brief Summary

Currently there is little consensus regarding postoperative antibiotic prophylactic treatment and its effect on the postoperative infection rate after Cochlear implantation. The literature on this subject is contradictory, and very limited. The aim is to assess the impact of postoperative antibiotic treatment on post-operative infection rate, and thereby discuss if postoperative antibiotic treatment has any benefits in the preventing treatment against infectious complication.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-01
• Status Verified: 2023-12
• Study First Submitted: 2023-12-10
• Study First Submitted QC: 2023-12-10
• Study First Posted: 2023-12-20
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-07
• Primary Completion: 2024-07-30
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 920

Inclusion Criteria

• All patients undergoing cochlear implantation at this facility from 2010 to 2022

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Postoperative prophylactics	Antibiotic	Patients receiving postoperative prophylactic antibiotic treatment

Primary Outcome Measures

Name	Time	Method
Infection rate	1 year	Number of infected patients

Secondary Outcome Measures

Name	Time	Method
Infection type	1 year	Number of patients with minor and severe infections

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark