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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06177444
Other study ID # 23/46599
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 1, 2023
Est. completion date August 1, 2024

Study information

Verified date December 2023
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 920
Est. completion date August 1, 2024
Est. primary completion date July 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 0 Years to 120 Years
Eligibility Inclusion Criteria: - All patients undergoing cochlear implantation at this facility from 2010 to 2022 Exclusion Criteria: - none

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Antibiotic
Postoperative antibiotic treatment

Locations

Country Name City State
Denmark Odense University Hospital Odense

Sponsors (2)

Lead Sponsor Collaborator
Odense University Hospital Odense Patient Data Explorative Network

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Infection rate Number of infected patients 1 year
Secondary Infection type Number of patients with minor and severe infections 1 year
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