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

• Status: Completed
• Trial end date: 2020-10-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Centre Ljubljana
• Collaborators: University of Ljubljana; University of Ljubljana, Faculty of Medicine

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