A New Predictor Marker for Cochlear Implants Infection

NCT04120181 | Completed

• 1 other identifier: 2019/01
• Study Type: observational
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Infection; Implant Infection; Cochlear Hearing Loss

Keywords

Neutrophil-to-lymphocyte ratio; Platelet-to-lymphocyte ratio; cochlear implant; artificial implant; infection

Outcome Measures

Primary Outcomes (1)

• 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.

  2014-2018

Secondary Outcomes (1)

• Determine which NLR is susceptible to infection

  2014-2018

Study Arms (1)

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.

Other: There is no intervention.

Interventions

There is no intervention. OTHER

There is no intervention.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• \) Patients who developed implant infection after receiving cochlear implant at the Department of Otorhinolaryngology, Selcuk University Hospital between March 2014 - August 2018.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Selcuk University: lead

Related Publications (7)

• 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.

  PMID: 23478648 BACKGROUND

• Brady 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.

  PMID: 20214837 BACKGROUND

• Wei 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.

  PMID: 17418257 BACKGROUND

• Zahorec 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.

  PMID: 11723675 BACKGROUND

• Seretis 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.

  PMID: 23388425 BACKGROUND

• Senturk 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.

  PMID: 27068888 BACKGROUND

• Onal 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.

  PMID: 36544965 DERIVED

MeSH Terms

Conditions

Infections; Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 9, 2019
• Study Start: May 1, 2014
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 10, 2019

Record last verified: 2019-10