Comparison of Topical Use of Platelet-rich Plasma Versus Hyaluronic Acid During Endoscopic Fat Graft Myringoplasty
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- graft taking
研究概览
简要总结
This study aimed to compare the effect of adding HA versus PRP to endoscopic FGM in cases of small or medium-sized central TM perforation in the form of:
- Evaluation of the graft uptake rate.
- Evaluation and comparing audiological outcomes.
- Finding out intraoperative and postoperative morbidity.
详细描述
Tympanic membrane (TM) perforations result in recurrent middle ear infection and hearing loss. Both these hazards can be prevented by the reconstructive surgery of the tympanic membrane.
Fat graft myringoplasty (FGM) has been reported as a suitable procedure to close long-standing TM perforations FGM is an efficient, safe and potentially fast method for TM perforation repairing with a success rate varies from 79% to 91%..Many researches was done to use supporting material in myringoplasty Saliba et al used hyaluronic acid fat graft myringoplasty [HAFGM] and results in a higher success rate than using FGM alone. El-Anwar et al proved that Topical autologous platelet-rich plasma(PRP) application during myringolpasty is safe, efficient and enhances healing of TM perforation PRP includes many autologous growth factors that have significant functions like cell proliferation, migration, and angiogenesis. Fibrin and fibronectin are essential proteins in PRP that provide the structural support needed for the cell migration, cell proliferation, and 3-dimensional growth of tissues.
HA has been shown to play a role in cellular signaling, leukocyte growth and migration, Cell adhesion and biological remodeling and is mainly involved in tissue healing with a central role in modulating inflammatory responses also, Its absorption of water causes expansion in volume and formation of a viscoelastic gel which constitutes a favorable scaffold for tissue regeneration and remodeling .
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, Care Provider)
入排标准
- 年龄范围
- 14 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with central small or median sized dry perforation
- •Aged between 14 and 50 years
- •In cases of CSOM the perforation must be dry with no otorrhea with healthy middle ear mucosa for at least three month without medications
- •Conductive gap on audiometry not more than 40 dB.
排除标准
- •Discharging CSOM .
- •Concurrent URTI .
- •CSOM with dry marginal perforation
- •Patients who didn't come for follow up.
- •Age less than 14 or more than
- •Unsafe CSOM with cholesteatoma, apparent retraction pockets, granulations, or extensive myringosclerosis reaching the edges of the perforation. Patients
- •Patients who are suspected of having Eustachian tube dysfunction.
- •Suspected ossicular pathology in safe CSOM if the ABG > 40dB.
- •Patients with history of Previous ear surgery.
- •Patients unfit for surgery or having chronic medical illness.
- •Narrow external auditory canal.
- •Patients who refused to enrolled in our study
- •Patients with sensorineural hearing loss or only functioning ear.
结局指标
主要结局
graft taking
时间窗: 3 months
Endoscopic examination of TM: Graft will considered as successfully taken if there is no residual TM perforation after 3 months postoperativly.
次要结局
- Otorrhea(1 month)
- Audiotympanogram(3 months)
研究者
Ahmed Gamal Abdel-Hameed
assistant lecture of otolaryngeology
Assiut University