N/A
Completed N=24
Efficacy of Platelet- and Extracellular Vesicle-rich Plasma in Chronic Postsurgical Temporal Bone Inflammations
Otitis Media Chronic · Temporal Bone
Source: ClinicalTrials.gov NCT04281901 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: Change in Inflammation Surface Area. — 100; 100; 43; 135 percentage of the baseline surface
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Inflammation Surface Area. |
100; 100; 43; 135; 36; 144 | — |
| PRIMARY Change in Chronic Otitis Media Questionnaire 12 Score |
32; 31; 22; 34; 20; 33 | — |
| SECONDARY Bacterial Presence |
7; 9; 4; 4 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04281901). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.