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

NCT04281901 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-08-03

Study results available
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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

Interventions

DRUG

Platelet- and extracellular vesicle-rich plasma

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

DRUG

Standard conservative treatment

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

Sponsors & Collaborators

  • University of Ljubljana

    collaborator OTHER

  • University of Ljubljana, Faculty of Medicine

    collaborator OTHER

  • University Medical Centre Ljubljana

    lead OTHER

Principal Investigators

  • Saba Battelino, MD, PhD · Department of Otorhinolaryngology and Cervicofacial Surgery, UMC Ljubljana

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-20
Primary Completion
2020-04-15
Completion
2020-10-14

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04281901 on ClinicalTrials.gov