A Randomized, Parallel-Group (Autogenous EVPOME Versus AlloDerm Without Incorporation of Keratinocytes) Study in Subjects Reconstructed With Large Defect Mandibular Resection in Need of Vestibuloplasty for Dental Rehabilitation
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Percent Graft Contracture
研究概览
简要总结
The purpose of this study is to compare the safety and effectiveness of performing oral reconstructive surgeries using either AlloDerm, a product commonly used for this purpose, or AlloDerm that has been overlaid with the subject's oral mucosal cells and developed into a type of graft that is called an ex vivo produced oral mucosal equivalent, EVPOME.
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
- 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
- •Be an adult over 18 years of age
- •Have a free fibular graft placed more than six months ago that has been used for restoration of mandibular continuity.
- •Be in need of surgery to increase the vestibular fold of the grafted mandible for placement of a dental prosthesis to restore function
排除标准
- •Any liver, kidney, heart, blood, metabolic or systemic disease which may make execution of the protocol of interpretation of the results difficult
- •A history of syphilis, HIV, Hepatitis B or Hepatitis C
- •Pregnancy or planning to become pregnant
- •Known or suspected allergy to bovine (cow) protein
- •Receiving radiation
- •Currently smoking or using tobacco products
- •Talking medication that can result in gingival enlargement (Cyclosporine, Dilantin, calcium channel blockers)
- •Allergy to any of the following antibiotics Gentamycin, Cefoxitin, Lincomycin, Polymyxin B, Vancomycin, cephalosporins, or clindamycin
- •Allergy to Polysorbate 20
研究组 & 干预措施
AlloDerm
The subject will be treated with the standard of care, AlloDerm, to cover the defect in the mouth.
干预措施: AlloDerm (Biological)
EVPOME
An ex-vivo produced oral mucose equivalent (EVPOME) will be used to cover the defect in the top of the mouth.
干预措施: EVPOME (Biological)
结局指标
主要结局
Percent Graft Contracture
时间窗: 2-24 weeks
During surgery, after preparation of the recipient bed, the recipient bed and the graft will be measured for the maximum distance between non-resorbable sutures placed at the margins of the graft. Post-surgical measurements of the graft site will be taken at visits 5, 6, 7, and 8 and compared to original graft size to assess percentage of graft contracture.
次要结局
- Degree of Epithelialized Tissue(4 weeks after surgery)
- Laser Doppler Flowmetry (LDF)(Visit 1 and 2 and 4 weeks after surgery)
研究者
Stephen E. Feinberg
Professor & Associate Chair of Research
University of Michigan