Efficacy of Platelet- and Extracellular Vesicle-rich Plasma in Chronic Postsurgical Temporal Bone Inflammations (PvRP-ear)

August 2, 2021 updated by: Domen Vozel, MD, University Medical Centre Ljubljana

Efficacy of Platelet- and Extracellular Vesicle-rich Plasma for the Treatment of Chronically Inflamed Post-surgical Temporal Bone Cavities: a Randomised Controlled Clinical Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • University Medical Centre Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: Platelet- and extracellular vesicle-rich plasma
ear wick soaked in platelet- and extracellular vesicle-rich plasma
ACTIVE_COMPARATOR: 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).
Drug: Standard conservative treatment
standard conservative measures, including antimicrobials, antiseptics and aural toilette for treating a chronically inflamed radical cavity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Inflammation Surface Area.
Time Frame: Baseline, 1 month, 2 months and 3 months after baseline

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
Time Frame: Baseline, 1 month, 2 months and 3 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bacterial Presence
Time Frame: Baseline, 2 months
The microbiological analysis included incubation of smear samples to cultivate bacteria, present in postsurgical temporal bone cavity inflammation. Microscopical analyses of colonies were performed to identify the presence of bacteria. Bacteria were absent if no colonies were identified.
Baseline, 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Collaborators

University of Ljubljana
University of Ljubljana, Faculty of Medicine

Investigators

  • Study Chair: Saba Battelino, MD, PhD, Department of Otorhinolaryngology and Cervicofacial Surgery, UMC Ljubljana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 20, 2019

Primary Completion (ACTUAL)

April 15, 2020

Study Completion (ACTUAL)

October 14, 2020

Study Registration Dates

First Submitted

February 20, 2020

First Submitted That Met QC Criteria

February 20, 2020

First Posted (ACTUAL)

February 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0120-146/2019/5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD relevant for the results will be shared

IPD Sharing Time Frame

Data will be available from the beginning of the study until the conclusion.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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