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临床试验/NCT07350642
NCT07350642尚未招募不适用

Efficacy of Platelet Rich Plasma Injection for Vocal Fold Sulcus, Scar and Atrophy

Assiut University0 个研究点目标入组 48 人开始时间: 2025年12月29日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
48

研究概览

简要总结

a study to asses safety and efficacy of platelet rich plasma injection in some types of vocal fold problems such as sulcus and atrophy to see the improvement in patient voice and its impact on patient quality of life with a good period of follow up

详细描述

Vocal fold sulcus, atrophy and scarring are significant causes of dysphonia that present major therapeutic challenges for laryngologists. The etiology of vocal fold scarring is diverse, including phonotrauma, iatrogenic injury from phonomicrosurgery or intubation, malignancy, and radiation therapy. In addition, age-related changes such as the loss of hyaluronic acid, elastic fibers, and bulk causes atrophy can reduce the viable tissue mass.

Vocal fold atrophy leads to reduced pliability and impaired vibratory capacity of the vocal folds. Atrophy is commonly associated with aging (presbyphonia), but it may also result from denervation, disuse, or systemic conditions that affect muscle mass and extracellular matrix composition.

Sulcus vocalis is a structural vocal fold disorder characterized by the presence of a longitudinal furrow along the free edge of the vocal fold. It represents part of the spectrum of SLP disorders, as it involves abnormal thinning, tethering, or loss of the lamina propria, leading to reduced vibratory function. The condition can be congenital, due to defective vocal fold development, or acquired, often associated with chronic inflammation, phonotrauma, or previous vocal fold lesions.

Scarring, atrophy, and sulcus vocalis represent a spectrum of SLP disorders that share pathological features, including inflammatory changes, collagen dysregulation, and depletion of glycosaminoglycans such as hyaluronic acid. Unlike vocal fold paralysis where medialization techniques may restore glottic contact these conditions respond poorly to standard medialization procedures, as glottic gap is not the sole issue. Similarly, exogenous fillers may produce suboptimal vibratory characteristics due to differences in biomechanical properties between artificial materials and native SLP tissue.

These pathological changes primarily affect the superficial lamina propria (SLP) of the vocal folds, an essential layer that provides the viscoelasticity and tensile strength necessary for normal oscillation and sound production.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
10 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1-Age ≥ 10 years 2-Gender: both sexes will be included in the study 3-clinical diagnosis of vocal fold sulcus, scar or atrophy. 4-Diagnosis confirmed by video laryngoscope examination. 5-be able to participate and sign informed consent.

排除标准

  • 1- Laryngeal cancer.
  • Acute laryngeal infection .
  • Systemic diseases that may impair healing, such as:(Uncontrolled diabetes mellitus-Autoimmune disorders affecting the larynx-Coagulopathy or bleeding disorders).
  • 4. Use of systemic corticosteroids or immunosuppressive drugs within the last 4 weeks.
  • 5. Previous laryngeal surgery within the last 6 months
  • Pregnancy or lactation.
  • Known allergy or hypersensitivity to local anesthetics or any component used in PRP preparation.
  • 8. Inability to complete with follow-up visits or voice assessment protocols

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aya Esam Sharkawy

Assistant lecture

Assiut University

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