UnknownPhase 2/3

Use of Autologous Plasma Rich in Platelets and Extracellular Vesicles in the Surgical Treatment of Chronic Middle Ear Infections

Slovenia100 participantsStarted 2021-02-14

Plain-language summary

This clinical study evaluates the efficacy of the autologous blood-derived product called platelet- and extracellular vesicle-rich plasma as a supplement to the surgical treatment of chronic tympanic membrane perforations. Half of the participants will be treated with standard surgical procedure called tympanoplasty and addition of platelet- and extracellular vesicle-rich plasma. Another half will be treated with only the standard tympanoplasty.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * tympanic membrane, * dry middle ear cavity, * absence of exclusion criteria. Exclusion Criteria: * signs of cholesteatoma, * anemia, * thrombocytopenia, * chronic use of immunomodulatory agents and / or antimicrobials, * malignancy in the ear area, * systemic infectious disease, * autoimmune disease, * inability and / or refusal of the patient to participate in the research, * pregnancy and / or breast-feeding.

What they're measuring

Change of tympanic membrane perforation size

Timeframe: Baseline (1 day pre-operatively), 6 weeks, 3 months and 6 months after surgery.

Change in Chronic Otitis Media Questionnaire 12 score

Timeframe: Baseline (1 day pre-operatively), 6 months after surgery.

Trial details

NCT IDNCT04761562

SponsorUniversity Medical Centre Ljubljana

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-30

Contact for this trial

Nejc Steiner, MD

+38615223280 nejc.steiner@kclj.si

View on ClinicalTrials.gov More Otitis Media Chronic trials