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

• Status: Recruiting
• Trial end date: 2023-09-30
• 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 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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Centre Ljubljana
• Collaborator: University of Ljubljana

Criteria

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.