Using of Acellular Dermal Matrix in Cleft Palatal Fistula and Compare With Use of Conchal Cartolage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Fistula formation
研究概览
简要总结
The fact that still exist is which method for repairing of secondary cleft palatal fistula is the best. This study will have shown whether using of Acellular dermal Matrix decreased the fistula formation versus using Conchal Cartilage during secondary fistula. Among studies that published, they have not consensus for using acellular dermal matrix. Most of the questions are about cost effectiveness, time that surgery and rehabilitation need and patient risk ( risk of transmission disease from other human tissue )
详细描述
Observational study composed of a prospective cohort group receiving ADM compared to a retrospective historical cohort group with Conchal Cartilage.
Primary objectives:
The primary objective of this study is to determine whether ADM would lower the incidence of palatal fistula in patients undergoing secondary cleft palate fistula repair.
Secondary objectives:
- hypo nasality speech after surgery
- Improvement Speech Score
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed as having cleft palate fistula, with ADM will be included in this study.
排除标准
- •Selection will be based on the patient's willingness to allow to participate in the study.
- •Patients with diagnosed craniofacial syndromes will be excluded from the study.
- •Children with known wound healing defects, will be excluded from the study.
结局指标
主要结局
Fistula formation
时间窗: Within 2 year of surgery
次要结局
未报告次要终点
研究者
Meisam AbdarEsfahani
Using of Acellular Dermal Matrix in cleft palatal fistula and compare with Use of Conchal Cartolage
Isfahan University of Medical Sciences