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

NCT04281901 | Completed Results

• 1 other identifier: 0120-146/2019/5
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Otitis Media Chronic; Temporal Bone

Keywords

Otitis Media; Mastoidectomy; Wound Healing; Platelet-Rich Plasma; Extracellular Vesicles; Cholesteatoma; Regenerative Medicine

Outcome Measures

Primary Outcomes (2)

• Change in Inflammation Surface Area.

  The inflamed tissue in the postoperative temporal bone cavity was observed and photographed otomicroscopically. Then the surface area of the inflamed tissue was determined by using ZEN 3.0 blue edition software(©Carl Zeiss Microscopy GmbH, 2019). Values in square millimetres were transformed to the ratios of the inflamed surface area according to the baseline surface area. The baseline surface area values are therefore 100% for each case or participant.

  Baseline, 1 month, 2 months and 3 months after baseline

• Change in Chronic Otitis Media Questionnaire 12 Score

  Sum score of Chronic Otitis Media Questionnaire 12 (COMQ-12), patient-reported health-related quality of life measure. Each question is scored from 0 to 5 points, therefore the minimum score value is 0 and the maximum 60. A higher score means worse chronic otitis media-related quality of life. A higher change in COMQ-12 score means a better treatment outcome.

  Baseline, 1 month, 2 months and 3 months

Secondary Outcomes (1)

• Bacterial Presence

  Baseline, 2 months

Study Arms (2)

PVRP treated participants

EXPERIMENTAL

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.

Drug: Platelet- and extracellular vesicle-rich plasma

Standardly treated participants

ACTIVE COMPARATOR

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).

Drug: Standard conservative treatment

Interventions

Platelet- and extracellular vesicle-rich plasma DRUG

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

PVRP treated participants

Standard conservative treatment DRUG

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

Standardly treated participants

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead
• University of Ljubljana: collaborator
• University of Ljubljana, Faculty of Medicine: collaborator

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (3)

• 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.

  PMID: 28156006 BACKGROUND

• 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.

  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.

  PMID: 34307321 RESULT

MeSH Terms

Conditions

Otitis Media; Cholesteatoma

Interventions

Platelet Count

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Platelet Function Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Results Point of Contact

• Title: Domen Vozel, M.D., Saba Battelino, M.D., PhD.
• Organization: Department of Otorhinolaryngology and Cervicofacial Surgery, University Medical Centre Ljubljana, Ljubljana, Slovenia. Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.

domen.vozel@kclj.si

+386 (0)1 522 83 07

Study Officials

• Saba Battelino, MD, PhD

  Department of Otorhinolaryngology and Cervicofacial Surgery, UMC Ljubljana

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A person unaware of the participants and their random allocation will measure inflammation area with computer software provided by ZEN Lite, Zeiss.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Participants treated with PVRP will receive PVRP-soaked ear wicks at the day of recruitment, additionally 1 month later and then followed-up twice in 1-month intervals. Participants not treated with PVRP will be treated with standard conservative nonsurgical measures with the same follow-up time.

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: February 24, 2020
• Study Start: March 20, 2019
• Primary Completion: April 15, 2020
• Study Completion: October 14, 2020
• Last Updated: August 3, 2021
• Results First Posted: August 13, 2020

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available from the beginning of the study until the conclusion.
• Access Criteria: Access for the data affecting results will be provided. Access to this data will be provided by the central contact person or central contact backup. No personal identification information will be provided.

Locations

SL (1)