Use of Autologous Plasma Rich in Platelets and Extracellular Vesicles in the Surgical Treatment of Chronic Otitis Media
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change of tympanic membrane perforation size
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •tympanic membrane,
- •dry middle ear cavity,
- •absence of exclusion criteria.
排除标准
- •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.
研究组 & 干预措施
Control group
Patients will be treated with a standard surgical procedure - tympanoplasty.
干预措施: Control group (Procedure)
PVRP group
Patients will be treated with a standard surgical procedure - tympanoplasty combined with PVRP. PVRP will be applied to the reconstructed tympanic membrane.
干预措施: Platelet- and extracellular vesicle-rich plasma (Drug)
结局指标
主要结局
Change of tympanic membrane perforation size
时间窗: 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
时间窗: 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.
次要结局
- Change in hearing threshold level(Baseline (1 day pre-operatively), 6 weeks, 3 months and 6 months after surgery.)
研究者
Nejc Steiner
Principal Investigator, Resident of otorhinolaryngology
University Medical Centre Ljubljana