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临床试验/CTRI/2024/04/065658
CTRI/2024/04/065658已完成3 期

Comparison of outcomes of myringoplasty using Temporalis fascia alone and Temporalis fascia with Platelet Rich Fibrin sheet - an Academic trial

Dept of ENT AIIMS Mangalagiri1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2024年5月1日最近更新:

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

发起方
Dept of ENT AIIMS Mangalagiri
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Lalam Rama Varaha Rohini

AIIMS Mangalagiri

研究点 (1)

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