Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06316635
Status:
RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-10
Brief Title:
Microplastics in Otitis Media With Effusion Material
Sponsor:
Kerem Kökoğlu
Organization:
TC Erciyes University
Study Overview
Official Title:
Evaluation of Microplastics Presence in Otitis Media With Effusion Material
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Microplastic rate is increasing ib athmosphere They can be found in lung kidney heart even placenta Otitis media with effusion OME is a clinical condition that is ver common in children Biofilms are blamed in the pathogenesis of OME Microplastics can include biofilms Importance of microplastics for potential pathogens and their toxicity aspects should be enlighted with studies This study aims to investigate presency of microplastics in middle ear fluid of patients with OME
Detailed Description:
This study was planned prospectively With ethical approvel patients who were followed by bilateral OME at least for three months or one-sided OME at least for 9 months were enrolled to the study Patients with craniofacial anomaly cleft palate had history of previous ear surgery were excluded They were operated as paracentesis and ventilation tube implementation VTI An informed consent form was obtained from them and their parents
Operation Surgical indication was made according to disease duration andor hearing loss Patients were operated under general anesthesia Paracentesis was made from posteroinferior quadrant of tympanic membrane Glu material was trapped in the suction tube and tranferred to glass tubes immediately Figure 1 For this glass syringe and 09 serum physiologic were used Samples were sent from right and left ear seperately Microplastics determination was made in Enviromental Engineering Labaratory of Faculty of Engineering
Microplastics Determination Method It applied according to Prada et al report 11 Fragments except blood clots were washed with a jet of filtered distilled water inside the laminar flow hood to remove any surface contamination and all samples were weighed inside closed glass flasks to the nearest 01 mg Sartorius Entris Germany A method for preparing biological samples for Nile Red staining previously developed and tested was followed 16 i incubation for 24 h at 60 C Oasis Benchtop IR CO2 Incubator Caron OH USA in 30 mL of 10 KOH wv 85 Labchem PA USA ii at 24 h the temperature was raised to boiling point and the solution immediately filtered on glass fiber filter membrane 12 µm pore Whatman GFC Little Chalfont Buckinghamshire UK mounted in a vacuum glass filtration system iii 100 mL of boiling filtered distilled water was filtered to remove soaps iv 10 mL of acetone was added to the cup for 10 min v an additional 10 mL of acetone was filtered to remove lipophilic matter vi 05-1 mL of 001 mg mL-1 of Nile Red microscopy grade Sigma-Aldrich St Louis MO USA was added to the cup for 5 min vii 50 mL of distilled water was filtered and viii stored in glass Petri dishes kept inside cardboard boxes for a week to dry at room temperature 20 C
Contamination Control Measures Strict contamination control measures were conducted in all phases namely by i wearing cotton lab coats and clean gloves ii working in the laminar flow hood in a clean room maintained by cleaning with ethanol in paper towels followed by cleaning with a duster that attracts and traps dust particles and paper fibers iii filtering all solutions 12 µm pore Whatman GFC iv using glass and metal materials v decontaminating glass materials by submerging them in 10 HNO3 for at least 30 min and rinsing with distilled water vi additionally cleaning glass Petri dishes with a N2 air jet vii burning glass microfiber filter membranes at 450 C for 3 h viii cleaning the cup of the filtration system between samples by dipping it for 15 s in a solution first batch acetone second batch 30 HNO3 followed by dipping in distilled water ix keeping sample containers closed as much as possible with glass lids caps or aluminum foil and x conducting procedural blanks solutions without samples exposed to sample preparation procedures for each batch Each samples were tested by three times for verification In addition microplastics were evaluated in serum psyisologic to prevent contamination
Operation Surgical indication was made according to disease duration andor hearing loss Patients were operated under general anesthesia Paracentesis was made from posteroinferior quadrant of tympanic membrane Glu material was trapped in the suction tube and tranferred to glass tubes immediately Figure 1 For this glass syringe and 09 serum physiologic were used Samples were sent from right and left ear seperately Microplastics determination was made in Enviromental Engineering Labaratory of Faculty of Engineering
Microplastics Determination Method It applied according to Prada et al report 11 Fragments except blood clots were washed with a jet of filtered distilled water inside the laminar flow hood to remove any surface contamination and all samples were weighed inside closed glass flasks to the nearest 01 mg Sartorius Entris Germany A method for preparing biological samples for Nile Red staining previously developed and tested was followed 16 i incubation for 24 h at 60 C Oasis Benchtop IR CO2 Incubator Caron OH USA in 30 mL of 10 KOH wv 85 Labchem PA USA ii at 24 h the temperature was raised to boiling point and the solution immediately filtered on glass fiber filter membrane 12 µm pore Whatman GFC Little Chalfont Buckinghamshire UK mounted in a vacuum glass filtration system iii 100 mL of boiling filtered distilled water was filtered to remove soaps iv 10 mL of acetone was added to the cup for 10 min v an additional 10 mL of acetone was filtered to remove lipophilic matter vi 05-1 mL of 001 mg mL-1 of Nile Red microscopy grade Sigma-Aldrich St Louis MO USA was added to the cup for 5 min vii 50 mL of distilled water was filtered and viii stored in glass Petri dishes kept inside cardboard boxes for a week to dry at room temperature 20 C
Contamination Control Measures Strict contamination control measures were conducted in all phases namely by i wearing cotton lab coats and clean gloves ii working in the laminar flow hood in a clean room maintained by cleaning with ethanol in paper towels followed by cleaning with a duster that attracts and traps dust particles and paper fibers iii filtering all solutions 12 µm pore Whatman GFC iv using glass and metal materials v decontaminating glass materials by submerging them in 10 HNO3 for at least 30 min and rinsing with distilled water vi additionally cleaning glass Petri dishes with a N2 air jet vii burning glass microfiber filter membranes at 450 C for 3 h viii cleaning the cup of the filtration system between samples by dipping it for 15 s in a solution first batch acetone second batch 30 HNO3 followed by dipping in distilled water ix keeping sample containers closed as much as possible with glass lids caps or aluminum foil and x conducting procedural blanks solutions without samples exposed to sample preparation procedures for each batch Each samples were tested by three times for verification In addition microplastics were evaluated in serum psyisologic to prevent contamination
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| self-funding | OTHER | Erciyes University | None |