Efficacy of Platelet- and Extracellular Vesicle-rich Plasma in Chronic Postsurgical Temporal Bone Inflammations

NCT ID: NCT04281901

Last Updated: 2021-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-20
• Study Completion Date: 2020-10-14

Brief Summary

This clinical study evaluates the efficacy of the autologous blood-derived product called platelet- and extracellular vesicle-rich plasma (PVRP) for the treatment of chronically inflamed post-surgical temporal bone cavities. Half of the participants will be treated with platelet- and extracellular vesicle-rich plasma and another half with standard nonsurgical measures.

Detailed Description

The hypothesis of this study is that platelet- and extracellular vesicle-rich plasma (PVRP) may be efficient in the treatment of chronically inflamed post-surgical temporal bone cavities.

Platelet-rich plasma (PRP) is a well-known autologous blood-derived product with favourable immune, haemostatic and regenerative effects. It has been used in various medical fields including otorhinolaryngology.

In fact, PRP contains important concentrations of extracellular vesicles (EV) which are the main contributors to PRP effects. For that reason, PRP can be identified as platelet- and extracellular vesicle-rich plasma (PVRP). In this study, PVRP will be prepared by a unique non-commercial 2-step centrifugation protocol developed by this study researchers.

A radical cavity is a large post-surgical temporal bone cavity due to removal of the posterior external ear canal wall in open-technique cholesteatoma surgery. This technique is performed in approximately 40 per cent of cholesteatoma surgery.

Radical cavities become inflamed in 3-20 per cent, which leads to the formation of granulation tissue and multiple suppurative periods. The large spectrum of surgical and nonsurgical treatment options have been applied to reduce patient discomfort. This significantly worsens the patients' quality of life and puts a significant burden on health care.

Due to the knowledge of local immune response mechanisms in moist radical cavities and exhausted treatment options, new conservative treatment options have been researched. PVRP could present a promising treatment option for chronically inflamed radical cavities based on published preclinical and clinical studies.

PVRP will be administered to chronically inflamed radical cavities via PVRP-soaked ear wicks.

Conditions

Otitis Media Chronic; Temporal Bone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PVRP treated participants

Participants will receive PVRP in the chronically inflamed radical cavity at the baseline evaluation (day 0) and 1 month later (1. follow-up). There will be 2 additional follow-ups with a 1-month interval.

Group Type: EXPERIMENTAL

Platelet- and extracellular vesicle-rich plasma

Intervention Type: DRUG

ear wick soaked in platelet- and extracellular vesicle-rich plasma

Standardly treated participants

Participants will receive standard conservative measures for the chronically inflamed radical cavity at the baseline evaluation (day 0), 1 month later (1. follow-up), 2 months later (2. follow-up) and 3 months later (3. follow-up).

Group Type: ACTIVE_COMPARATOR

Standard conservative treatment

Intervention Type: DRUG

standard conservative measures, including antimicrobials, antiseptics and aural toilette for treating a chronically inflamed radical cavity.

Interventions

Platelet- and extracellular vesicle-rich plasma

ear wick soaked in platelet- and extracellular vesicle-rich plasma

Intervention Type: DRUG

Standard conservative treatment

standard conservative measures, including antimicrobials, antiseptics and aural toilette for treating a chronically inflamed radical cavity.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• chronic otitis media, defined as a presence of at least 1 of the following: visible ear discharge, indirect signs of ear discharge (e.g. on a pillow, clothes), ear itching, the sensation of ear fullness, clinical signs of acute exacerbation of chronic otitis media during an otomicroscopic examination.
• non-cholesteatomatous chronic otitis media despite prior standard conservative treatment
• non-cholesteatomatous chronic otitis media despite prior surgical treatment

Exclusion Criteria

• the presence or suspicion of cholesteatoma
• infection of venepuncture site
• pregnancy
• breastfeeding
• long-term treatment with antimicrobial drugs
• long-term treatment with immunosuppressant drugs
• the presence of systemic infectious disease
• the presence of an autoimmune disease
• the presence of cancer
• receiving other types of experimental treatment for chronic otitis media

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ljubljana

OTHER

Sponsor Role: collaborator

University of Ljubljana, Faculty of Medicine

OTHER

Sponsor Role: collaborator

University Medical Centre Ljubljana

OTHER

Sponsor Role: lead

Responsible Party

Domen Vozel, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Saba Battelino, MD, PhD

Role: STUDY_CHAIR

Department of Otorhinolaryngology and Cervicofacial Surgery, UMC Ljubljana

Locations

University Medical Centre Ljubljana

Ljubljana, , Slovenia

Countries

Slovenia

References

Vozel D, Ursic B, Krek JL, Stukelj R, Kralj-Iglic V. Applicability of extracellular vesicles in clinical studies. Eur J Clin Invest. 2017 Apr;47(4):305-313. doi: 10.1111/eci.12733. Epub 2017 Feb 28.

Reference Type: BACKGROUND

PMID: 28156006 (View on PubMed)

Uršič B, Vozel D, Šuštar V, Kocjančič B, Dolinar D, Kralj-Iglič V. Extracellular Vesicles from Platelet-Rich Plasma as Conveyors of Regeneration Potential in Orthopedics. J Hematol Thromboembolic Dis 2(5), 2014.

Reference Type: BACKGROUND

Vozel D, Bozic D, Jeran M, Jan Z, Pajnic M, Paden L, Steiner N, Kralj-Iglic V, Battelino S. Autologous Platelet- and Extracellular Vesicle-Rich Plasma Is an Effective Treatment Modality for Chronic Postoperative Temporal Bone Cavity Inflammation: Randomized Controlled Clinical Trial. Front Bioeng Biotechnol. 2021 Jul 7;9:677541. doi: 10.3389/fbioe.2021.677541. eCollection 2021.

Reference Type: RESULT

PMID: 34307321 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

0120-146/2019/5

Identifier Type: -

Identifier Source: org_study_id