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NCT Number: NCT04281901

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

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.

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Key information

Conditions

Otitis Media Chronic Cholesteatoma Ear Diseases Keratosis Otitis Otitis Media Otorhinolaryngologic Diseases Skin Diseases Skin and Connective Tissue Diseases Temporal Bone

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet- and extracellular vesicle-rich plasma

Drug

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

Standard conservative treatment

Drug

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Collaborators

  • University of Ljubljana
  • University of Ljubljana, Faculty of Medicine

Registry information

Official study title

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

Acronym: PvRP-ear

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 24, 2020
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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