The Use of Chitosan Succinamide (Chitogel CSK-4) Gel as Packing in Tympanoplasty Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- External auditory canal healing
研究概览
简要总结
Little innovation in the material used for middle ear packing has occurred over the past decade, despite the fact that animal models have shown increased acute inflammation and increased fibrosis in the long term histologically. Although Chitosan Succinamide has shown improved wound healing and hemostasis in the nasal cavity mucosa, it has yet to be used as a support material, hemostatic agent, and healing agent in the middle ear. This study will utilize Chitosan Succinamide as an alternative to purified gelatin foam as a support material in primary tympanoplasty surgery.
详细描述
A prospective cohort study will be performed. Healthy adults (age > 18) with single tympanic membrane perforations who have been offered and agreed to undergo tympanoplasty surgery with fascia graft (either transcanal or post-auricular) will be recruited. The surgical intervention and procedure of tympanoplasty will be performed as normal, however, the packing material will be randomly chosen using a random number generator. The middle ear and external canal will then be packed with either Chitosan Succinamide or Gelfoam. The patients in both groups will be placed on ciprodex post-operatively for 4 weeks. The patients will be seen post-operatively at 1 week for photo documentation and removal of the lateral aspect of CS/CD or Gelfoam. The patients will be seen at 4 weeks for photo documentation and the remainder of packing removal. At 3 months and 1 year the patients will have photo documentation and an audiogram.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy adults
- •Single tympanic membrane perforation
排除标准
- •Chronic recurrent infection or otorrhea
- •Previous ear surgery for the study ear
- •Shellfish allergy
- •Cerebral Spinal Fluid (CSF) leak concern
研究组 & 干预措施
Packing with Gelfoam
Tympanoplasty surgery with fascia graft (either transcanal or post-auricular) will be preformed. The middle ear and external canal will then be packed with Gelfoam.
干预措施: Gelfoam (Biological)
Packing with Chitosan succinamide
The surgical intervention and tympanoplasty will be performed as normal. The middle ear and external canal will be packed Chitosan succinamide.
干预措施: Chitosan succinamide (Biological)
结局指标
主要结局
External auditory canal healing
时间窗: Assess healing of auditory canal starting 1 week up to one year following surgery.
Physician determines exposed bone and inflammatory response
Tympanic membrane healing
时间窗: Assess healing of auditory canal starting 1 week up to one year following surgery.
Physician determines failed tympanic membrane healing and inflammatory response.
次要结局
未报告次要终点