Efficacy of Platelet Enriched Plasma in Preventing Surgery for Patients With Chronic Tympanic Membrane Perforation
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Prevention of Patients Requiring Surgery
研究概览
简要总结
By doing this study, researchers hope to find out if platelet rich plasma (PRP) can heal holes in the eardrum as an alternative to surgery.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet criteria for tympanoplasty procedure
- •Willing to comply with the protocol and attend all study visits
- •Able to provide written informed consent
排除标准
- •Patients who have previously undergone middle ear or lateral skull base surgery
- •Patients who would not qualify for a tympanoplasty
- •Any type of platelet disorder, cancer, or ongoing systemic infection
- •Any type of hemodynamic instability, septicemia, infection, tobacco use, any use of steroids to the ear drums
- •Type I diabetes or other autoimmune pathology
研究组 & 干预措施
PRP Treatment
Participants receive platelet rich plasma treatment. Participants will be asked to make up to 5 trips to the clinic (one for eligibility, one for the PRP, three follow-up visits). Participation is expected to last up to about 6 weeks. After the second visit and application of PRP, patients will be monitored closely for any complications or concerns. This will include a follow up phone call 3-5 days after the initial application of PRP. Patients will also be followed closely in 2 week intervals or sooner should any problems or concerns arise.
干预措施: Platelet Rich Plasma (Biological)
结局指标
主要结局
Prevention of Patients Requiring Surgery
时间窗: 6 Weeks
Number of participants that are able to avoid surgery for their perforation.
次要结局
- Time to Healing(6 Weeks)
研究者
Hinrich Staecker, MD, PhD
Professor
University of Kansas Medical Center