Use of Autologous Plasma Rich in Platelets and Extracellular Vesicles in the Surgical Treatment of Chronic Otitis Media
Overview
- Phase
- Phase 2
- Intervention
- Control group
- Conditions
- Otitis Media Chronic
- Sponsor
- University Medical Centre Ljubljana
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Change of tympanic membrane perforation size
- Last Updated
- 5 years ago
Overview
Brief 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.
Detailed Description
The study is designed to be mono-centric, prospective, double-blind, parallel, uniformly randomised, controlled, with a fixed sample. The purpose of the study is to determine whether autologous platelet- and extracellular vesicle-rich plasma (PVRP) made from peripheral venous blood, promotes healing of tympanic membrane perforations, improves hearing and quality of life after surgical procedure called tympanoplasty. Tympanoplasty is a surgical procedure in which the surgeon refreshes the edges of the perforation of the eardrum and thus encourage re-healing of the eardrum. The tympanic membrane lies in the air, thus a tissue (muscle fascia, perichondrium, fat or cartilage) has to be put underneath the perforation and eardrum remnant. This then serves as a guide for the newly formed tympanic cells can outgrow the perforation. Patients attending outpatient examinations will be included in the study if they meet the inclusion criteria. Included patients will be randomised in two groups. Patients from the control group will be treated with a standard surgical treatment - tympanoplasty. The surgical procedure for the patients from the treatment group will be the same as for the control group, for the exception that PVRP will be added around the tympanic membrane remnant. PVRP will be activated inside (endogenous) and outside (exogenous) the body. Postoperatively patients will be assessed at examinations using an endoscope, otomicroscope, Chronic otitis media questionnaire and tests of hearing and balance. Laboratory blood tests will determine the presence of possible inflammation and assess the composition of the preparation. Research hypotheses * Hypothesis 1: In the group of patients treated with platelet-rich plasma and extracellular vesicles, the proportion of healed tympanic surfaces in terms of initial perforation will be higher than in patients treated without platelet-rich plasma and extracellular vesicles. * Hypothesis 2: In the group of patients treated with platelet-rich plasma and extracellular vesicles, complete healing of the tympanic membrane will occur to a greater extent than in patients treated without platelet-rich plasma and extracellular vesicles. * Hypothesis 3: In the group of patients treated with platelet-rich plasma and extracellular vesicles, hearing improvement will be greater than in patients treated with platelet-rich plasma and extracellular vesicles. * Hypothesis 4: The quality of life of patients with larger perforations assessed with the COMQ-12 questionnaire will be lower than in patients treated without platelet-rich plasma and extracellular vesicles. * Hypothesis 5: The quality of life assessed by the COMQ-12 questionnaire will be better in the group of patients treated with platelet-rich plasma and extracellular vesicles than in patients treated without platelet-rich plasma and extracellular vesicles.
Investigators
Nejc Steiner
Principal Investigator, Resident of otorhinolaryngology
University Medical Centre Ljubljana
Eligibility Criteria
Inclusion Criteria
- •tympanic membrane,
- •dry middle ear cavity,
- •absence of exclusion criteria.
Exclusion Criteria
- •signs of cholesteatoma,
- •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.
Arms & Interventions
Control group
Patients will be treated with a standard surgical procedure - tympanoplasty.
Intervention: Control group
PVRP group
Patients will be treated with a standard surgical procedure - tympanoplasty combined with PVRP. PVRP will be applied to the reconstructed tympanic membrane.
Intervention: Platelet- and extracellular vesicle-rich plasma
Outcomes
Primary Outcomes
Change of tympanic membrane perforation size
Time Frame: Baseline (1 day pre-operatively), 6 weeks, 3 months and 6 months after surgery.
The size of the tympanic membrane perforation will be expressed as proportion of the total surface area of the tympanic membrane. Number of pixels on an endoscopic photograph of the tympanic membrane will be measured with a computer program. The measured number of perforation pixels will be divided by the measured number of pixels of the entire tympanic membrane. The measurement will be performed by two doctors and the average value of the measured proportion of the drum surface used.
Change in Chronic Otitis Media Questionnaire 12 score
Time Frame: Baseline (1 day pre-operatively), 6 months after surgery.
* the unabbreviated scale title: Chronic Otitis Media Questionnaire 12 * the minimum and maximum values: 0, 60 * higher scores mean a worse outcome. Sum score of Chronic Otitis Media Questionnaire 12 (COMQ-12), patient-reported health-related quality of life measure. Questionnaire consists of 12 questions, each question is scored from 0 to 5 points.
Secondary Outcomes
- Change in hearing threshold level(Baseline (1 day pre-operatively), 6 weeks, 3 months and 6 months after surgery.)