Postoperative InfectionNCT06177444
Post-operative Antibiotics; Effects on Risk of Infection After Cochlear Implant Surgery
An observational study of Postoperative Infection, run by Odense University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 0 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Infection
- What is being tested?
- Antibiotic
- How many people
- 920 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2023to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 120 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older 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.
Who may be able to join
- All patients undergoing cochlear implantation at this facility from 2010 to 2022
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-operative Antibiotics; Effects on Risk of Infection After Cochlear Implant Surgery: A Retrospective Comparison
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.
- Conditions
- Postoperative Infection
- Being tested
- Antibiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticDrug
Postoperative antibiotic treatment
| Study group | Role | What they receive |
|---|---|---|
| Postoperative prophylactics | Patients receiving postoperative prophylactic antibiotic treatment Receives: Drug: Antibiotic | |
| non-postoperative prophylactics | Patients NOT receiving postoperative prophylactic antibiotic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection rate
Number of infected patients
Measured: 1 year
Secondary outcomes (1)
Infection type
Number of patients with minor and severe infections
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start1 Sep 2023
- Primary completion30 Jul 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative InfectionStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 920 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Odense Patient Data Explorative Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177444
- Sponsor's protocol ID
- 23/46599
- Status last verified
- Dec 2023
- First submitted
- 10 Dec 2023
- Last updated
- 7 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Antibiotics; Effects on Risk of Infection After Cochlear Implant Surgery: A Retrospective Comparison
- ClinicalTrials.gov ID
- NCT06177444
- Acronym / sponsor ID
- 23/46599
- Conditions
- Postoperative Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 920 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Odense Patient Data Explorative Network
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 20 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postoperative prophylactics | – | Drug: AntibioticPatients receiving postoperative prophylactic antibiotic treatment |
| non-postoperative prophylactics | – | –Patients NOT receiving postoperative prophylactic antibiotic treatment |
Who may qualify
- Ages
- 0 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older 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.
Key inclusion criteria (1 listed)
- All patients undergoing cochlear implantation at this facility from 2010 to 2022
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntibioticPostoperative antibiotic treatment | Drug | Postoperative prophylactics |
Primary outcome
Infection rate
Time frame: 1 year
Number of infected patients
1 secondary outcome
Infection type
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
Related trials for Postoperative Infection
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
RecruitingObservational study
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Surgical Site Infection
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Not yet recruitingPhase 3
Efficacy of Integrating Next Generation Sequencing for Treatment of Surgical Site Infection After Fracture Fixation:
Next Generation Sequencing (NGS), Surgical Site Infection (SSI)
RecruitingPhase 4
Antibiotic Tissue Penetration and Tissue Response in Head and Neck Infection and Reconstructive Surgery
Surgical Wound Infection, Neck Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Infection, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.