Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06290219
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-04
First Post:
2024-02-25
Brief Title:
The Effect of Platelet-rich Plasma Nasal Injection in the Treatment of Traumatic Olfactory Dysfunction
Sponsor:
Taichung Veterans General Hospital
Organization:
Taichung Veterans General Hospital
Study Overview
Official Title:
The Effect of Platelet-rich Plasma and Hyaluronic Acid Nasal Injection in the Treatment of Traumatic Olfactory Dysfunction
Status:
NOT_YET_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:
PRP
Brief Summary:
The purpose of this study is to explore the efficacy of injecting high-concentration platelet plasma combined with hyaluronic acid into the nasal olfactory mucosa in the treatment of traumatic anosmia
Detailed Description:
Causes of olfactory impairment include sinus diseases post-viral olfactory dysfunction neurological diseases and post-traumatic lesions of the olfactory nerve Since the outbreak of the COVID-19 in 2019 there has been a significant increase in the number of patients suffering from olfactory disorders and the duration of loss of smell and taste varies According to follow-up studies nearly 46 of those patients still have symptoms of olfactory impairment one year after diagnosis and nearly 7 have even completely lost their ability to smell In recent years injecting platelet-rich plasma into the nasal cavity has been a new method to improve the sense of smell The effects of platelet-rich plasma can reduce chronic inflammation and cell-related damage and promote regeneration of olfactory tissue while hyaluronic acid can promote the release of growth factors from platelets
The purpose of this study is to explore the efficacy of injecting high-concentration platelet plasma combined with hyaluronic acid into the nasal olfactory mucosa in the treatment of traumatic anosmia A total of 80 patients with olfactory dysfunction were collected from otolaryngology head and neck outpatient clinics Selection criteria are 18 years of age or older and loss of olfactory function for more than 6 months after head trauma Exclusion criteria are pregnant or lactating women patients with compromised immune function patients with acute or chronic sinus infection patients with nasal polyps patients with a history of sinonasal cancer and patients with low platelets or hemophilia and other blood and blood cell-related diseases
This study will establish experimental groups and control groups according to random distribution Subjects in both groups received zinc tablets and olfactory training for 12 weeks The experimental group additionally received an injection of platelet-rich plasma combined with hyaluronic acid After treatment patients return to the clinic to track the olfactory condition
Before treatment the subjects evaluated their olfactory function using a Visual Analogue Scale VAS and performed the phenyl ethyl alcohol odor detection threshold test and the traditional Chinese version of the University of Pennsylvania Olfactory Identification Test In the experimental group 10cc of blood will be drawn from the subjects in the experimental group the drawn blood will be centrifuged the centrifuge tube will be inverted 20 times to mix the plasma and hyaluronic acid and finally 5cc of the plasma mixed with hyaluronic acid will be drawn out using an empty syringe The project investigator injects plasma mixed with hyaluronic acid into the nasal septum and the medial side of the middle turbinate of the patients nasal cavity under a nasal endoscope The two groups will undergo the same olfactory tests three months later to compare the changes in olfactory function of the two groups of patients before and after treatment to explore the efficacy of injecting high-concentration platelet plasma combined with hyaluronic acid into the nasal olfactory mucosa to treat traumatic anosmia
The purpose of this study is to explore the efficacy of injecting high-concentration platelet plasma combined with hyaluronic acid into the nasal olfactory mucosa in the treatment of traumatic anosmia A total of 80 patients with olfactory dysfunction were collected from otolaryngology head and neck outpatient clinics Selection criteria are 18 years of age or older and loss of olfactory function for more than 6 months after head trauma Exclusion criteria are pregnant or lactating women patients with compromised immune function patients with acute or chronic sinus infection patients with nasal polyps patients with a history of sinonasal cancer and patients with low platelets or hemophilia and other blood and blood cell-related diseases
This study will establish experimental groups and control groups according to random distribution Subjects in both groups received zinc tablets and olfactory training for 12 weeks The experimental group additionally received an injection of platelet-rich plasma combined with hyaluronic acid After treatment patients return to the clinic to track the olfactory condition
Before treatment the subjects evaluated their olfactory function using a Visual Analogue Scale VAS and performed the phenyl ethyl alcohol odor detection threshold test and the traditional Chinese version of the University of Pennsylvania Olfactory Identification Test In the experimental group 10cc of blood will be drawn from the subjects in the experimental group the drawn blood will be centrifuged the centrifuge tube will be inverted 20 times to mix the plasma and hyaluronic acid and finally 5cc of the plasma mixed with hyaluronic acid will be drawn out using an empty syringe The project investigator injects plasma mixed with hyaluronic acid into the nasal septum and the medial side of the middle turbinate of the patients nasal cavity under a nasal endoscope The two groups will undergo the same olfactory tests three months later to compare the changes in olfactory function of the two groups of patients before and after treatment to explore the efficacy of injecting high-concentration platelet plasma combined with hyaluronic acid into the nasal olfactory mucosa to treat traumatic anosmia
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