Comparison of outcomes of myringoplasty using Temporalis fascia alone and Temporalis fascia with Platelet Rich Fibrin sheet - an Academic trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- graft uptake
研究概览
简要总结
Myringoplasty is defined as surgical closure of tympanic membrane perforation, without reconstruction of ossicular chain. It is used in the treatment of chronic otitis media. Chronic suppurative otitis media (CSOM) is a long-standing infection of a part or whole of the middle ear cleft characterized by ear discharge and a permanent perforation. It is also the single most important cause of hearing impairment in rural population. Platelet-rich fibrin (PRF) is an autogenous material that is derived from a person’s own platelets and is used to enhance wound healing and tissue regeneration. PRF is proposed to have a direct effect on enhancing a patient’s wound healing by suprasaturating the wound with growth factors that promote tissue healing. Clinically, PRF is easily produced bedside from the patient’s own blood. Platelet rich fibrin is composed of an assembly of a cytokines, glycaemic chains, and structural glycoproteins enmeshed within a slowly polymerised fibrin network. These biochemical components help in healing through synergistic mechanisms. PRF hastens the cell proliferation and also offers inflammatory protection to grafts. As PRF membrane has a strong, elastic fibrin structure containing growth factors, it may improve graft uptake and healing.
Data regarding effect of PRF sheet in repair of chronic tympanic membrane perforations is limited and therefore the present study is being conducted to evaluate graft uptake and hearing improvement with the usage of PRF sheet in repair of chronic tympanic membrane perforation along with temporalis fascia and comparing the outcomes with conventional myringoplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients of chronic otitis media with inactive mucosal type.
- •2.Patients with conductive hearing loss less than 40 db.
- •3.Age group between 18-60 Years.
- •4.Patients With inactive ear for atleast 6 weeks.
排除标准
- •1.Patients with sensorineural hearing loss.
- •2.Pregnancy.
- •3.Patients with bleeding diathesis.
- •4.Patients with ossicular chain abnormalities.
- •5.Patients with mastoiditis, cholesteatoma and granulation tissue in middle ear.
- •Patients who refuses consent for PRF.
- •7.Patients with comorbidities like uncontrolled diabetes, hypertension, nasal allergies and COPD.
- •8.Patients with previous middle ear surgery, nasopharyngeal or skull base pathologies.
结局指标
主要结局
graft uptake
时间窗: 6 weeks
次要结局
- change in hearing threshold(3 months)
研究者
Lalam Rama Varaha Rohini
AIIMS Mangalagiri
