InfectionNCT04120181
A New Predictor Marker for Cochlear Implants Infection
An observational study of Infection and Implant Infection, run by Selcuk University.
Trial summary
Introduction: Surgical site infections associated with the cochlear implant can have serious consequences. Although advances in surgical techniques reduce these complications, it may be necessary to remove a device that works as a last resort as a result of ongoing infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Implant Infection, Cochlear Hearing Loss
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Oct 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study included 13 patients who developed implant infection after receiving cochlear implant at the Department of Otorhinolaryngology, Selcuk University Hospital between March 2014 - August 2018. The control group consists of 13 age- and gender-matched subjects who underwent CI surgery but showed no complications.
Who may be able to join
- 1) Patients who developed implant infection after receiving cochlear implant at the Department of Otorhinolaryngology, Selcuk University Hospital between March 2014 - August 2018.
- -
Who cannot join
- 1) Patients who had hematological disorders. 2) Diseases that retard tissue healing, such as diabetes, renal failure, or skin disease those who had experienced an impact on the head implant area.
- -
About this study
Official title: A New Predictor Marker for Cochlear Implants Infection: Neutrophil/ Lymphocyte Ratio
Introduction: Surgical site infections associated with the cochlear implant can have serious consequences. Although advances in surgical techniques reduce these complications, it may be necessary to remove a device that works as a last resort as a result of ongoing infection. The removal of these devices, which are very expensive, increases the cost and takes the chance of hearing patients with this device. Therefore, it is very important to identify patients with a tendency to cochlear implant infection before surgery and to prevent these infections from occurring. Neutrophil/ lymphocyte ratio (NLR) and platelet/ lymphocyte ratio (PLR) are indicative of systemic inflammation and have a prognostic value in relation to mortality and morbidity in many diseases. The aim of this study was to identify patients with post-operative implant infection tendency in patients to be implanted with cochlear implant and to plan treatment for possible infections before cochlear implant, to reduce cost by preventing removal of implanted cochlear implant due to infection and to prevent the patient's chance of hearing through the cochlear implant from disappearing due to infection.
Methods: In this retrospective study, 13 patients with cochlear implant infection were included. Preoperative NLR was calculated by dividing the neutrophil (NEU) value by the lymphocyte (LYM) value and preoperative PLR was calculated by dividing the NEU value by the LYM value.
Read the detailed description
A cochlear implant (CI) is a device that restores the sense of hearing in people with severe to profound hearing loss. This implant consists of two parts: The first is an internal component, which is surgically implanted under the skin behind the ear and connected to electrodes that are inserted inside the cochlea. The second is an external component that sits behind the ear and consists of a speech processor, a microphone, and a battery compartment. However, complications following device implantation may occur; these complications include flap erosion, local infections, general infections that may lead to meningitis, wound healing disorders, electrode insertion, device migration, and facial nerve injury (1,2). The incidence of infectious complications is quite uncommon, but potentially serious complication of CI surgery occurs at a rate of 1.7% to 4.1% (3-5). CI infection may be managed with conservative treatment modalities; however, persistent infection often ends in implant removal or implant replacement (6).
The body responds to inflammation and stress, including trauma, surgery, or sepsis, by elevating the neutrophil count and by reducing the lymphocyte count (7). Neutrophil/ lymphocyte ratio (NLR) is an indicator of poor prognostic factor in inflammation and in some diseases, such as obstructive sleep apnea syndrome, ischemic cardiac diseases, several types of cancer, and Bell's palsy (8-11). Platelet/ lymphocyte ratio (PLR) is also associated with inflammation and poor prognosis in patients with different types of cancer (12,13). Platelets release proinflammatory mediators, such as chemokines and cytokines (14). NLR and PLR can be calculated from complete blood count (CBC), a cheap and simple means of obtaining information regarding inflammation. During an inflammatory reaction, the amount of leukocytes in the circulation changes (9,15).
The relationship of preoperative NLR and PLR with CI infection has not yet been investigated and it is being aimed to show the predictive value of NLR and PLR in patients who developed implant infection after CI placement. First outcome is to compare whether there is a difference between NLR in patients with and without implant infection in patients with cochlear implant implantation. Secondary outcome is to determine which NLR is susceptible to infection if there is a difference between NLR between patients with and without implant infection.
- Conditions
- Infection, Implant Infection, Cochlear Hearing Loss
- Being tested
- There is no intervention.
- Keywords
- Neutrophil-to-lymphocyte ratio, Platelet-to-lymphocyte ratio, cochlear implant, artificial implant, infection
- Medical subject headings
- Infections, Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention.Other
There is no intervention.
| Study group | Role | What they receive |
|---|---|---|
| Control | The control group consists of 13 age- and gender-matched subjects who underwent CI surgery but showed no complications. The members of the control group were selected based on hospital records. Receives: Other: There is no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between NLR in patients with and without implant infection
Our first outcome is to compare whether there is a difference between NLR in patients with and without implant infection in patients with cochlear implant implantation.
Measured: 2014-2018
Secondary outcomes (1)
Determine which NLR is susceptible to infection
Our Secondary outcome is to determine which NLR is susceptible to infection if there is a difference between NLR between patients with and without implant infection.
Measured: 2014-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study startMay 2014
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozkan Onal, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120181
- Sponsor's protocol ID
- 2019/01
- Status last verified
- Oct 2019
- First submitted
- 7 Oct 2019
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kanaan N, Winkel A, Stumpp N, Stiesch M, Lenarz T. Bacterial growth on cochlear implants as a potential origin of complications. Otol Neurotol. 2013 Apr;34(3):539-43. doi: 10.1097/MAO.0b013e3182829792.
PubMed 23478648Brady AJ, Farnan TB, Toner JG, Gilpin DF, Tunney MM. Treatment of a cochlear implant biofilm infection: a potential role for alternative antimicrobial agents. J Laryngol Otol. 2010 Jul;124(7):729-38. doi: 10.1017/S0022215110000319. Epub 2010 Mar 10.
PubMed 20214837Wei BP, Shepherd RK, Robins-Browne RM, Clark GM, O'Leary SJ. Threshold shift: effects of cochlear implantation on the risk of pneumococcal meningitis. Otolaryngol Head Neck Surg. 2007 Apr;136(4):589-96. doi: 10.1016/j.otohns.2006.11.039.
PubMed 17418257Zahorec R. Ratio of neutrophil to lymphocyte counts--rapid and simple parameter of systemic inflammation and stress in critically ill. Bratisl Lek Listy. 2001;102(1):5-14. English, Slovak.
PubMed 11723675Seretis C, Gourgiotis S, Gemenetzis G, Seretis F, Lagoudianakis E, Dimitrakopoulos G. The significance of neutrophil/lymphocyte ratio as a possible marker of underlying papillary microcarcinomas in thyroidal goiters: a pilot study. Am J Surg. 2013 Jun;205(6):691-6. doi: 10.1016/j.amjsurg.2012.08.006. Epub 2013 Feb 4.
PubMed 23388425Senturk M, Azgin I, Ovet G, Alatas N, Agirgol B, Yilmaz E. The role of the mean platelet volume and neutrophil-to-lymphocyte ratio in peritonsillar abscesses. Braz J Otorhinolaryngol. 2016 Nov-Dec;82(6):662-667. doi: 10.1016/j.bjorl.2015.11.018. Epub 2016 Mar 28.
PubMed 27068888Onal M, Colpan Keles B, Ulusoy B, Onal O. New validation of a well-known marker in cochlear implant infections: A retrospective, case-controlled, observational study. Laryngoscope Investig Otolaryngol. 2022 Nov 24;7(6):1992-2001. doi: 10.1002/lio2.900. eCollection 2022 Dec.
PubMed 36544965
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Predictor Marker for Cochlear Implants Infection: Neutrophil/ Lymphocyte Ratio
- ClinicalTrials.gov ID
- NCT04120181
- Acronym / sponsor ID
- 2019/01
- Conditions
- Infection, Implant Infection, Cochlear Hearing Loss
- Keywords
- Neutrophil-to-lymphocyte ratio, Platelet-to-lymphocyte ratio, cochlear implant, artificial implant, infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 9 Oct 2019 (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.
Introduction: Surgical site infections associated with the cochlear implant can have serious consequences. Although advances in surgical techniques reduce these complications, it may be necessary to remove a device that works as a last resort as a result of ongoing infection. The removal of these devices, which are very expensive, increases the cost and takes the chance of hearing patients with this device. Therefore, it is very important to identify patients with a tendency to cochlear implant infection before surgery and to prevent these infections from occurring. Neutrophil/ lymphocyte ratio (NLR) and platelet/ lymphocyte ratio (PLR) are indicative of systemic inflammation and have a prognostic value in relation to mortality and morbidity in many diseases. The aim of this study was to identify patients with post-operative implant infection tendency in patients to be implanted with cochlear implant and to plan treatment for possible infections before cochlear implant, to reduce cost by preventing removal of implanted cochlear implant due to infection and to prevent the patient's chance of hearing through the cochlear implant from disappearing due to infection.
Methods: In this retrospective study, 13 patients with cochlear implant infection were included. Preoperative NLR was calculated by dividing the neutrophil (NEU) value by the lymphocyte (LYM) value and preoperative PLR was calculated by dividing the NEU value by the LYM value.
Detailed description
A cochlear implant (CI) is a device that restores the sense of hearing in people with severe to profound hearing loss. This implant consists of two parts: The first is an internal component, which is surgically implanted under the skin behind the ear and connected to electrodes that are inserted inside the cochlea. The second is an external component that sits behind the ear and consists of a speech processor, a microphone, and a battery compartment. However, complications following device implantation may occur; these complications include flap erosion, local infections, general infections that may lead to meningitis, wound healing disorders, electrode insertion, device migration, and facial nerve injury (1,2). The incidence of infectious complications is quite uncommon, but potentially serious complication of CI surgery occurs at a rate of 1.7% to 4.1% (3-5). CI infection may be managed with conservative treatment modalities; however, persistent infection often ends in implant removal or implant replacement (6).
The body responds to inflammation and stress, including trauma, surgery, or sepsis, by elevating the neutrophil count and by reducing the lymphocyte count (7). Neutrophil/ lymphocyte ratio (NLR) is an indicator of poor prognostic factor in inflammation and in some diseases, such as obstructive sleep apnea syndrome, ischemic cardiac diseases, several types of cancer, and Bell's palsy (8-11). Platelet/ lymphocyte ratio (PLR) is also associated with inflammation and poor prognosis in patients with different types of cancer (12,13). Platelets release proinflammatory mediators, such as chemokines and cytokines (14). NLR and PLR can be calculated from complete blood count (CBC), a cheap and simple means of obtaining information regarding inflammation. During an inflammatory reaction, the amount of leukocytes in the circulation changes (9,15).
The relationship of preoperative NLR and PLR with CI infection has not yet been investigated and it is being aimed to show the predictive value of NLR and PLR in patients who developed implant infection after CI placement. First outcome is to compare whether there is a difference between NLR in patients with and without implant infection in patients with cochlear implant implantation. Secondary outcome is to determine which NLR is susceptible to infection if there is a difference between NLR between patients with and without implant infection.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: There is no intervention.The control group consists of 13 age- and gender-matched subjects who underwent CI surgery but showed no complications. The members of the control group were selected based on hospital records. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study included 13 patients who developed implant infection after receiving cochlear implant at the Department of Otorhinolaryngology, Selcuk University Hospital between March 2014 - August 2018. The control group consists of 13 age- and gender-matched subjects who underwent CI surgery but showed no complications.
Key inclusion criteria (2 listed)
- 1) Patients who developed implant infection after receiving cochlear implant at the Department of Otorhinolaryngology, Selcuk University Hospital between March 2014 - August 2018.
- -
Key exclusion criteria (2 listed)
- 1) Patients who had hematological disorders. 2) Diseases that retard tissue healing, such as diabetes, renal failure, or skin disease those who had experienced an impact on the head implant area.
- -
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 |
|---|---|---|
| There is no intervention.There is no intervention. | Other | Control |
Primary outcome
Difference between NLR in patients with and without implant infection
Time frame: 2014-2018
Our first outcome is to compare whether there is a difference between NLR in patients with and without implant infection in patients with cochlear implant implantation.
1 secondary outcome
Determine which NLR is susceptible to infection
Time frame: 2014-2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Background: PubMed 23478648Kanaan N, Winkel A, Stumpp N, Stiesch M, Lenarz T. Bacterial growth on cochlear implants as a potential origin of complications. Otol Neurotol. 2013 Apr;34(3):539-43. doi: 10.1097/MAO.0b013e3182829792.
- Background: PubMed 20214837Brady AJ, Farnan TB, Toner JG, Gilpin DF, Tunney MM. Treatment of a cochlear implant biofilm infection: a potential role for alternative antimicrobial agents. J Laryngol Otol. 2010 Jul;124(7):729-38. doi: 10.1017/S0022215110000319. Epub 2010 Mar 10.
- Background: PubMed 17418257Wei BP, Shepherd RK, Robins-Browne RM, Clark GM, O'Leary SJ. Threshold shift: effects of cochlear implantation on the risk of pneumococcal meningitis. Otolaryngol Head Neck Surg. 2007 Apr;136(4):589-96. doi: 10.1016/j.otohns.2006.11.039.
- Background: PubMed 11723675Zahorec R. Ratio of neutrophil to lymphocyte counts--rapid and simple parameter of systemic inflammation and stress in critically ill. Bratisl Lek Listy. 2001;102(1):5-14. English, Slovak.
- Background: PubMed 23388425Seretis C, Gourgiotis S, Gemenetzis G, Seretis F, Lagoudianakis E, Dimitrakopoulos G. The significance of neutrophil/lymphocyte ratio as a possible marker of underlying papillary microcarcinomas in thyroidal goiters: a pilot study. Am J Surg. 2013 Jun;205(6):691-6. doi: 10.1016/j.amjsurg.2012.08.006. Epub 2013 Feb 4.
- Background: PubMed 27068888Senturk M, Azgin I, Ovet G, Alatas N, Agirgol B, Yilmaz E. The role of the mean platelet volume and neutrophil-to-lymphocyte ratio in peritonsillar abscesses. Braz J Otorhinolaryngol. 2016 Nov-Dec;82(6):662-667. doi: 10.1016/j.bjorl.2015.11.018. Epub 2016 Mar 28.
- Derived from this study: PubMed 36544965Onal M, Colpan Keles B, Ulusoy B, Onal O. New validation of a well-known marker in cochlear implant infections: A retrospective, case-controlled, observational study. Laryngoscope Investig Otolaryngol. 2022 Nov 24;7(6):1992-2001. doi: 10.1002/lio2.900. eCollection 2022 Dec.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection and Implant Infection, run by Selcuk University.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference between NLR in patients with and without implant infection (time frame: 2014-2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04120181, which also lists 7 linked publications.
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 10 Oct 2019.