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

Sponsors

Lead Sponsor: Seoul St. Mary's Hospital

Source Seoul St. Mary's Hospital
Brief 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

Overall Status Completed
Start Date June 8, 2017
Completion Date April 1, 2019
Primary Completion Date April 1, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
The change of mucociliary clearance function using the saccharin test 2, 4, 8, 12, and 24th week
Secondary Outcome
Measure Time Frame
The change of nasal symptoms using the Nasal Obstruction Symptom Evaluation(NOSE) Instrument 2, 4, 8, 12, and 24th week
The change of nasal symptoms using the Sino-Nasal outcome Test 20 2, 4, 8, 12, and 24th week
The change of nasal symptoms using the Visual analog scale 2, 4, 8, 12, and 24th week
Enrollment 22
Condition
Intervention

Intervention Type: Device

Intervention Name: Plasma rich platelet injection

Description: Plasma rich platelet injection with 26-gauge needle and 2cc syringe on inferior turbinate mucosa

Arm Group Label: platelet rich plasma injection group

Intervention Type: Device

Intervention Name: Saline nasal spray

Description: two puffs of isotonic saline nasal spray twice daily

Arm Group Label: platelet rich plasma injection group

Eligibility

Criteria:

Inclusion Criteria:

- Adults (>18 years)

- Complaint of atrophic rhinitis symptoms including nasal crusting, nasal burning sensation, and postnasal drip

- Atrophic rhinitis view on nasal endoscopic finding

- Patients who informed sufficient about other atrophic rhinitis treatment options including Young's operation, lubricants, or saline irrigation, but, want more other active treatment option.

Exclusion Criteria:

- Platelet related disorders

- Low serum platelet (<100,000/㎕)

- Other hematologic disorders

- Septicemia

- Take anticoagulant drugs

Gender: All

Minimum Age: 19 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Location
Facility: Seoul St. Mary's Hospital
Location Countries

Korea, Republic of

Verification Date

April 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Seoul St. Mary's Hospital

Investigator Full Name: Sung Won Kim

Investigator Title: Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: platelet rich plasma injection group

Type: Experimental

Description: To evaluate the safety and efficacy of plasma rich platelet injection on inferior turbinate mucosa in patients with atrophic rhinitis

Acronym ARPRP
Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: Platelet Rich Plasma Injection group : 12 patients anticipated Saline spray group : 12 patients anticipated

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov