Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04761562
Status:
UNKNOWN
Last Update Posted:
2021-02-21
First Post:
2021-02-12
Brief Title:
Use of Autologous Plasma Rich in Platelets and Extracellular Vesicles in the Surgical Treatment of Chronic Middle Ear Infections
Sponsor:
University Medical Centre Ljubljana
Organization:
University Medical Centre Ljubljana
Study Overview
Official Title:
Use of Autologous Plasma Rich in Platelets and Extracellular Vesicles in the Surgical Treatment of Chronic Otitis Media
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
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:
This clinical study evaluates the efficacy of the autologous blood-derived product called platelet- and extracellular vesicle-rich plasma as a supplement to the surgical treatment of chronic tympanic membrane perforations
Half of the participants will be treated with standard surgical procedure called tympanoplasty and addition of platelet- and extracellular vesicle-rich plasma Another half will be treated with only the standard tympanoplasty
Half of the participants will be treated with standard surgical procedure called tympanoplasty and addition of platelet- and extracellular vesicle-rich plasma Another half will be treated with only the standard tympanoplasty
Detailed Description:
The study is designed to be mono-centric prospective double-blind parallel uniformly randomised controlled with a fixed sample
The purpose of the study is to determine whether autologous platelet- and extracellular vesicle-rich plasma PVRP made from peripheral venous blood promotes healing of tympanic membrane perforations improves hearing and quality of life after surgical procedure called tympanoplasty
Tympanoplasty is a surgical procedure in which the surgeon refreshes the edges of the perforation of the eardrum and thus encourage re-healing of the eardrum The tympanic membrane lies in the air thus a tissue muscle fascia perichondrium fat or cartilage has to be put underneath the perforation and eardrum remnant This then serves as a guide for the newly formed tympanic cells can outgrow the perforation
Patients attending outpatient examinations will be included in the study if they meet the inclusion criteria Included patients will be randomised in two groups
Patients from the control group will be treated with a standard surgical treatment - tympanoplasty The surgical procedure for the patients from the treatment group will be the same as for the control group for the exception that PVRP will be added around the tympanic membrane remnant PVRP will be activated inside endogenous and outside exogenous the body
Postoperatively patients will be assessed at examinations using an endoscope otomicroscope Chronic otitis media questionnaire and tests of hearing and balance Laboratory blood tests will determine the presence of possible inflammation and assess the composition of the preparation
Research hypotheses
Hypothesis 1 In the group of patients treated with platelet-rich plasma and extracellular vesicles the proportion of healed tympanic surfaces in terms of initial perforation will be higher than in patients treated without platelet-rich plasma and extracellular vesicles
Hypothesis 2 In the group of patients treated with platelet-rich plasma and extracellular vesicles complete healing of the tympanic membrane will occur to a greater extent than in patients treated without platelet-rich plasma and extracellular vesicles
Hypothesis 3 In the group of patients treated with platelet-rich plasma and extracellular vesicles hearing improvement will be greater than in patients treated with platelet-rich plasma and extracellular vesicles
Hypothesis 4 The quality of life of patients with larger perforations assessed with the COMQ-12 questionnaire will be lower than in patients treated without platelet-rich plasma and extracellular vesicles
Hypothesis 5 The quality of life assessed by the COMQ-12 questionnaire will be better in the group of patients treated with platelet-rich plasma and extracellular vesicles than in patients treated without platelet-rich plasma and extracellular vesicles
The purpose of the study is to determine whether autologous platelet- and extracellular vesicle-rich plasma PVRP made from peripheral venous blood promotes healing of tympanic membrane perforations improves hearing and quality of life after surgical procedure called tympanoplasty
Tympanoplasty is a surgical procedure in which the surgeon refreshes the edges of the perforation of the eardrum and thus encourage re-healing of the eardrum The tympanic membrane lies in the air thus a tissue muscle fascia perichondrium fat or cartilage has to be put underneath the perforation and eardrum remnant This then serves as a guide for the newly formed tympanic cells can outgrow the perforation
Patients attending outpatient examinations will be included in the study if they meet the inclusion criteria Included patients will be randomised in two groups
Patients from the control group will be treated with a standard surgical treatment - tympanoplasty The surgical procedure for the patients from the treatment group will be the same as for the control group for the exception that PVRP will be added around the tympanic membrane remnant PVRP will be activated inside endogenous and outside exogenous the body
Postoperatively patients will be assessed at examinations using an endoscope otomicroscope Chronic otitis media questionnaire and tests of hearing and balance Laboratory blood tests will determine the presence of possible inflammation and assess the composition of the preparation
Research hypotheses
Hypothesis 1 In the group of patients treated with platelet-rich plasma and extracellular vesicles the proportion of healed tympanic surfaces in terms of initial perforation will be higher than in patients treated without platelet-rich plasma and extracellular vesicles
Hypothesis 2 In the group of patients treated with platelet-rich plasma and extracellular vesicles complete healing of the tympanic membrane will occur to a greater extent than in patients treated without platelet-rich plasma and extracellular vesicles
Hypothesis 3 In the group of patients treated with platelet-rich plasma and extracellular vesicles hearing improvement will be greater than in patients treated with platelet-rich plasma and extracellular vesicles
Hypothesis 4 The quality of life of patients with larger perforations assessed with the COMQ-12 questionnaire will be lower than in patients treated without platelet-rich plasma and extracellular vesicles
Hypothesis 5 The quality of life assessed by the COMQ-12 questionnaire will be better in the group of patients treated with platelet-rich plasma and extracellular vesicles than in patients treated without platelet-rich plasma and extracellular vesicles
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