Post-operative Antibiotics; Effects on Risk of Infection... | NCT06177444

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

NCT06177444

Sponsor

Odense University Hospital

Status

Unknown status

Last Update Posted

May 7, 2024Actual

Enrollment

920Estimated

Phase

Not provided

Conditions

Postoperative Infection

Interventions

Antibiotic

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2023Actual

Primary Completion Date

Jul 30, 2024Estimated

Completion Date

Aug 1, 2024Estimated

First Submitted Date

Dec 10, 2023

First Submission Date that Met QC Criteria

Dec 10, 2023

First Posted Date

Dec 20, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 3, 2024

Last Update Posted Date

May 7, 2024Actual

Name	Class
Odense Patient Data Explorative Network	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

920Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Postoperative prophylactics		Patients receiving postoperative prophylactic antibiotic treatment	Drug: Antibiotic
non-postoperative prophylactics		Patients NOT receiving postoperative prophylactic antibiotic treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Antibiotic	Drug	Postoperative antibiotic treatment	Postoperative prophylactics

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Infection rate	Number of infected patients	1 year

Secondary Outcomes

Measure	Description	Time Frame
Infection type	Number of patients with minor and severe infections	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

120 Years

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Odense University Hospital		Odense			Denmark

Intervention Browse Module

MeSH Terms

ID	Term
D000900	Anti-Bacterial Agents

Ancestor Terms

ID	Term
D000890	Anti-Infective Agents
D045506	Therapeutic Uses
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses

Browse Leaves

Not provided

Browse Branches

Not provided