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

NCT04761562 | Unknown Phase 2

• 1 other identifier: PVRPTY2021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Otitis Media Chronic; Tympanic Membrane Perforation

Keywords

Tympanoplasty; Platelet-Rich Plasma

Outcome Measures

Primary Outcomes (2)

• Change of tympanic membrane perforation size

  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.

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

• Change in Chronic Otitis Media Questionnaire 12 score

  * 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.

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

Secondary Outcomes (1)

• Change in hearing threshold level

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

Study Arms (2)

Control group

ACTIVE COMPARATOR

Patients will be treated with a standard surgical procedure - tympanoplasty.

Procedure: Control group

PVRP group

EXPERIMENTAL

Patients will be treated with a standard surgical procedure - tympanoplasty combined with PVRP. PVRP will be applied to the reconstructed tympanic membrane.

Drug: Platelet- and extracellular vesicle-rich plasma

Interventions

Platelet- and extracellular vesicle-rich plasma DRUG

PVRP will initially be applied to the gelatine sponge without prior exogenous activation, which will first be inserted into the middle ear cavity to support the reconstructed tympanic membrane. The remainder of the PVRP will then be exogenously activated with calcium chloride. Gel rich with platelets and extracellular vesicles will be created and applied on top of the reconstructed tympanic membrane. Finally, the external auditory canal will be filled with pieces of gelatine sponge soaked with PVRP.

PVRP group

Control group PROCEDURE

Edges of the tympanic membrane perforation will be refreshed and the tympanomeatal flap raised. Under the tympanic membrane perforation, a guide (fascia of the temporalis muscle, perichondrium, cartilage or fat) will be placed. An absorbent gelatin sponge will be placed under the guide and on the outer surface of the reconstructed tympanic membrane.

Also known as: Standard tympanoplasty

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• tympanic membrane,
• dry middle ear cavity,

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead
• University of Ljubljana: collaborator

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

Related Publications (2)

• Vozel D., Božič D., Jeran M., Jan Z., Pajnič M., Pađen L., Uršič B., Iglič A., Kralj-Iglič V., Battelino S. 2020. Treatment with platelet- and extracellular vesicle-rich plasma in otorhinolaryngology-a review and future perspectives. V Advances in Biomembranes and Lipid Self-Assembly. Academic Press. https://doi.org/10.1016/bs.abl.2020.05.003

  BACKGROUND

• Vozel D, Steiner N, Bozanic Urbancic N, Mladenov D, Battelino S. Slovenian Cross-Cultural Adaptation and Validation of Health-Related Quality of Life Measures for Chronic Otitis Media (COMQ-12), Vertigo (DHI, NVI) and TINNITUS (THI). Zdr Varst. 2020 Jun 25;59(3):120-127. doi: 10.2478/sjph-2020-0016. eCollection 2020 Sep.

  PMID: 32952712 BACKGROUND

MeSH Terms

Conditions

Tympanic Membrane Perforation

Interventions

Platelet Count; Control Groups

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Platelet Function Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods

Central Study Contacts

Nejc Steiner, MD

CONTACT

+38615223280; nejc.steiner@kclj.si

Saba Battelino, PhD, MD

CONTACT

+38615228307; saba.battelino@kclj.si

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Both the patient and the outcomes assessors of the tympanic membrane healing, hearing and questionnaires will not know in which group the patient was placed. The patient group will be known only to the doctoral student, the surgeon and the person who will prepare the PVRP. None of them will be included in the process randomisation and final assessment 3 and 6 months after surgery.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Resident of otorhinolaryngology

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 21, 2021
• Study Start: February 14, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

SL (1)