Infection Clinical Trial
Official title:
A New Predictor Marker for Cochlear Implants Infection: Neutrophil/ Lymphocyte Ratio
NCT number | NCT04120181 |
Other study ID # | 2019/01 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 2014 |
Est. completion date | October 2018 |
Verified date | October 2019 |
Source | Selcuk University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 13 |
Est. completion date | October 2018 |
Est. primary completion date | October 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1) Patients who developed implant infection after receiving cochlear implant at the Department of Otorhinolaryngology, Selcuk University Hospital between March 2014 - August 2018. - Exclusion Criteria: 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. - |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Selcuk University |
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. — View Citation
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. — View Citation
Sentürk M, Azgin I, Övet G, Alatas N, Agirgöl 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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 2014-2018 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04529421 -
Assocation Between In-person Instruction and COVID-19 Risk
|
||
Recruiting |
NCT04081792 -
Optimal Antibiotics for Operated Diabetic Foot Infections
|
N/A | |
Completed |
NCT04332861 -
Evaluation of Infection in Obstructing Urolithiasis
|
||
Recruiting |
NCT04674657 -
Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
|
||
Enrolling by invitation |
NCT05052203 -
Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
|
||
Recruiting |
NCT00342589 -
New Techniques for Using a Saline Wash as a Diagnostic Tool for Pneumocystis Pneumonia
|
||
Completed |
NCT03295825 -
Heparin Binding Protein in Early Sepsis Diagnosis
|
N/A | |
Completed |
NCT03296423 -
Bacillus Calmette-guérin Vaccination to Prevent Infections of the Elderly
|
Phase 4 | |
Withdrawn |
NCT04217252 -
Clinical Application of High-throughput Sequencing Technology for the Diagnosis of Patients With Severe Infection
|
N/A | |
Recruiting |
NCT02905552 -
Myelodysplasic Syndromes and Risk Factors for Infection
|
N/A | |
Recruiting |
NCT02899143 -
Short-course Antimicrobial Therapy in Sepsis
|
Phase 2 | |
Withdrawn |
NCT02904434 -
Gastrointestinal Implications of Voriconazole Exposure
|
||
Active, not recruiting |
NCT02768454 -
Antimicrobials Stewardship by Pharmacist
|
N/A | |
Completed |
NCT02219776 -
Decreasing Infection In Arthroscopic Shoulder Surgery
|
N/A | |
Completed |
NCT02210169 -
RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates
|
N/A | |
Recruiting |
NCT02098226 -
Evaluation of MALDI Biotyper CA System for Detection of Gram- and Gram+ Bacteria and Yeasts
|
N/A | |
Completed |
NCT01846832 -
A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection
|
Phase 3 | |
Terminated |
NCT01441206 -
Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants
|
Phase 1 | |
Completed |
NCT01434797 -
Value of PET/CT Imaging in the Diagnosis of Permanent Central Venous Catheters Infection
|
||
Completed |
NCT01159834 -
Human Papillomavirus (HPV) Vaccination in Barretos (Pio XII Foundation - Barretos Cancer Hospital)
|
N/A |