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

NCT03112330 | Completed

• 1 other identifier: CMCENT-01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrophic Rhinitis

Keywords

atrophic rhinitis

Outcome Measures

Primary Outcomes (1)

• The change of mucociliary clearance function using the saccharin test

  The change in saccharin test time of the 2, 4, 8, 12, and 24th week after first treatment

  2, 4, 8, 12, and 24th week

Secondary Outcomes (3)

• 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

Study Arms (1)

platelet rich plasma injection group

EXPERIMENTAL

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

Device: Plasma rich platelet injection; Device: Saline nasal spray

Interventions

Plasma rich platelet injection DEVICE

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

platelet rich plasma injection group

Saline nasal spray DEVICE

two puffs of isotonic saline nasal spray twice daily

platelet rich plasma injection group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Platelet related disorders
• Low serum platelet (\<100,000/㎕)
• Other hematologic disorders
• Septicemia
• Take anticoagulant drugs

Sponsors & Collaborators

• Seoul St. Mary's Hospital: lead

Study Sites (1)

Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

Related Publications (8)

• Friji MT, Gopalakrishnan S, Verma SK, Parida PK, Mohapatra DP. New regenerative approach to atrophic rhinitis using autologous lipoaspirate transfer and platelet-rich plasma in five patients: Our Experience. Clin Otolaryngol. 2014 Oct;39(5):289-92. doi: 10.1111/coa.12269. No abstract available.

  PMID: 24938860 BACKGROUND

• Marx RE. Platelet-rich plasma: evidence to support its use. J Oral Maxillofac Surg. 2004 Apr;62(4):489-96. doi: 10.1016/j.joms.2003.12.003. No abstract available.

  PMID: 15085519 BACKGROUND

• Hildenbrand T, Weber RK, Brehmer D. Rhinitis sicca, dry nose and atrophic rhinitis: a review of the literature. Eur Arch Otorhinolaryngol. 2011 Jan;268(1):17-26. doi: 10.1007/s00405-010-1391-z. Epub 2010 Sep 29.

  PMID: 20878413 BACKGROUND

• Mishra A, Kawatra R, Gola M. Interventions for atrophic rhinitis. Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD008280. doi: 10.1002/14651858.CD008280.pub2.

  PMID: 22336840 BACKGROUND

• Jaswal A, Jana AK, Sikder B, Nandi TK, Sadhukhan SK, Das A. Novel treatment of atrophic rhinitis: early results. Eur Arch Otorhinolaryngol. 2008 Oct;265(10):1211-7. doi: 10.1007/s00405-008-0629-5. Epub 2008 Mar 4.

  PMID: 18317788 BACKGROUND

• Modrzynski M. Hyaluronic acid gel in the treatment of empty nose syndrome. Am J Rhinol Allergy. 2011 Mar-Apr;25(2):103-6. doi: 10.2500/ajra.2011.25.3577.

  PMID: 21679513 BACKGROUND

• Canciani M, Barlocco EG, Mastella G, de Santi MM, Gardi C, Lungarella G. The saccharin method for testing mucociliary function in patients suspected of having primary ciliary dyskinesia. Pediatr Pulmonol. 1988;5(4):210-4. doi: 10.1002/ppul.1950050406.

  PMID: 3237448 BACKGROUND

• Stavrakas M, Karkos PD, Markou K, Grigoriadis N. Platelet-rich plasma in otolaryngology. J Laryngol Otol. 2016 Dec;130(12):1098-1102. doi: 10.1017/S0022215116009403.

  PMID: 27938467 BACKGROUND

MeSH Terms

Conditions

Rhinitis, Atrophic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Sung Won Kim, MD, PhD

  Seoul St. Mary's Hospital

  STUDY CHAIR

• Do Hyun Kim, MD, PhD

  Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 13, 2017
• Study Start: June 8, 2017
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: April 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)