Efficacy of Fat Graft Myringoplasty Versus Fat Plus Platelet Rich Plasma (PRP) Myringoplasty in Closing Smaller Tympanic Membrane Perforations in an Outpatient Setting: a Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 5
- 主要终点
- Presence or absence of tympanic membrane perforation
研究概览
简要总结
The current standard treatment for chronic tympanic membrane perforations (TMP) involves having fat grafted from the patient and inserted into the ear, through the perforation, to promote healing using the fat graft myringoplasty (FGM) technique. Platelet rich plasma (PRP) has also been used to promote TMP healing and involves having the patient provide a blood sample, which is processed to produce PRP and applied to the perforation. This prospective, multi-centre study will evaluate whether combining both these techniques can improve the rate of closure in patients with chronic TMP involving <50% of the membrane.
Patients will be randomized to receive either the standard FGM treatment or FGM treatment with the addition of PRP. At 3 months postintervention a blinded observer will rate the degree of TMP closure. Differences in closure rates between the 2 groups will be compared.
详细描述
This will be a multi-centre, single-blinded, randomised control trial. Patients will be randomised at each site to undergo FGM with or without PRP.
Step 1 in both groups is the same. Under LA (or GA if the patient is unable to tolerate this), a fat graft is taken from just behind the mastoid process, or more posteriorly just beneath the hairline if necessary. The graft is kept moist in 0.9% saline.The ear canal is injected with LA and the edges of the perforation are freshened. Gelfoam is placed into the middle ear and the fat graft placed on top of this until it touches the underside of the TM and slightly bulges through. In an attempt to achieve standardisation of surgical technique between sites, surgeons will be provided with an operative video to watch beforehand.
Step 2. The surgeon is informed of the randomisation outcome into Group 1 or 2. Group 1 (Non PRP): patients will have FGM alone, and this will simply be covered with a piece of saline-soaked Gelfoam cut to completely cover the perforation and graft.
Group 2 (PRP): as for Group 1, but the Gelfoam will instead be soaked in PRP derived from the patient's own whole blood. The generation of PRP is descibed below: -
- 10-20 mL of autologous blood collected from an antecubital vein is placed in an adenosine citrate dextrose-acid (ACD-A) collection tube to prevent premature activation
- Blood immediately placed in the centrifuge at 1100g for 10 minutes (once)
- Supernatant removed and collected into syringe
- Injected onto surface of fat graft
- Rest added to piece of gelfoam
- Place gelfoam + PRP on the TM perforation
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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tympanic membrane perforation measuring <50% of the area of the membrane
- •Perforation present for at least 6 months (based on history or direct observation)
- •All edges of perforation are visible
排除标准
- •Active ear infection at the time of the procedure
- •cholesteatoma present
- •Patients on immunosuppressive therapy (including oral steroids) or chemotherapy
- •Patients with previous failed attempt at perforation repair
结局指标
主要结局
Presence or absence of tympanic membrane perforation
时间窗: 3 months
次要结局
- Infection rate(3 months)
- Degree of perforation closure(3 months)
- Discomfort on using vinegar drops(2 weeks)