NCT06177444

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
920

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 20, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

May 7, 2024

Status Verified

December 1, 2023

Enrollment Period

11 months

First QC Date

December 10, 2023

Last Update Submit

May 3, 2024

Conditions

Postoperative Infection

Outcome Measures

Primary Outcomes (1)

  • Infection rate

    Number of infected patients

    1 year

Secondary Outcomes (1)

  • Infection type

    1 year

Study Arms (2)

Postoperative prophylactics

Patients receiving postoperative prophylactic antibiotic treatment

Drug: Antibiotic

non-postoperative prophylactics

Patients NOT receiving postoperative prophylactic antibiotic treatment

Interventions

AntibioticDRUG

Postoperative antibiotic treatment

Postoperative prophylactics

Eligibility Criteria

Age0 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who underwent a CI-procedure from January 2010 to December 2022, in the department of ORL at OUH, which is estimated to approximately 900 patients in total. There seems to be no study made with such a great sample-size, which therefore will have a major contribution to the knowledge on this subject.

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, Denmark

Location

MeSH Terms

Interventions

Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2023

First Posted

December 20, 2023

Study Start

September 1, 2023

Primary Completion

July 30, 2024

Study Completion

August 1, 2024

Last Updated

May 7, 2024

Record last verified: 2023-12

Locations

DK(1)