NCT03112330

A Clinical Study to Evaluate the Safety and Efficacy of Platelet Rich Plasma Injection for Atrophic Rhinitis

A Single-center, Non-randomized, Open, Single-arm Confirmatory Clinical Study to Evaluate the Safety and Efficacy of Platelet Rich Plasma Injection for Patients With Atrophic Rhinitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Seoul St. Mary's Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The goal of the suggested research is to develop a treatment option using platelet rich plasma injection for regeneration of atropic nasal mucosa. Specific aims of the suggested research is to (1) access the effect of platelet rich plasma in the patients with atropic rhinitis . Moreover, we will (2) compare the conservative treatments including saline nasal irrigation or saline nasal spray.

Detailed description

Clinical trials of platelet rich plasma injection for regeneration of atropic nasal mucosa. * Injection interval and follow-up duration * Injection interval 2 weeks (upto total 3 consecutive injection) * Follow-up duration: 6 months * Observation items, clinical assessment items and evaluation method * Access the nasal mucosal status using nasal speculum. * Access the nasal mucociliary function using saccharin test (primary outcome; once per month). * Fill in the nasal symptom scores using Nasal Obstruction Symptom Evaluation(NOSE) Instrument, Sino-Nasal outcome Test 20, and Visual analog scale (secondary outcome; once per month) * The other atrophic rhinitis patients who did not want to perform platelet rich plasma injection * Random allocation to saline nasal irrigation or saline nasal spray group * Perform same observation items, clinical assessment items and evaluation method as well as platelet rich plasma injection group

Conditions

• Atrophic Rhinitis

Interventions

Type	Name	Description
DEVICE	Plasma rich platelet injection	Plasma rich platelet injection with 26-gauge needle and 2cc syringe on inferior turbinate mucosa
DEVICE	Saline nasal spray	two puffs of isotonic saline nasal spray twice daily

Timeline

• Start date: 2017-06-08
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2017-04-13
• Last updated: 2019-04-04

Locations

1 site across 1 country: South Korea