Does Acellular Dermal Matrix Reduce Fistula Rate in Primary Palatoplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Fistula Formation
研究概览
简要总结
The goal of the present study is to definitely determine whether the use of acellular dermal matrix (ADM) during primary cleft palate repair decreases the rate of fistula formation. Although individual studies have described promising advantages to its use in cleft palate surgery, no consensus currently exists. Without concrete evidence, one must question the whether the increased cost, time and potential patient risk (human derived tissue) to patients justifies its use in primary cleft palate repair.
详细描述
There has been a change in the standard practice at the Montreal Children's Hospital where the senior author has shifted from selected application of ADM in certain cases to routine use of ADM in all cleft palate cases. This study is an observational study comparing a prospective cohort group receiving ADM routinely to a retrospective historical cohort group without routine use of ADM.
Objectives of the study:
Primary objectives:
The primary objective of this study is to determine whether routine use of ADM would lower the incidence of palatal fistula in patients undergoing primary cleft palate repair.
Secondary objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 3 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children diagnosed as having Veau class II to IV cleft palates undergoing Furlow palatoplasty with ADM between the ages of 3 months and 3 years will be included in this study.
排除标准
- •Selection will be based on the parent's willingness to allow their child to participate in the study.
- •Children with diagnosed craniofacial syndromes will be excluded from the study due their higher than usual incidence of palatal fistulas.
- •Children with known wound healing defects, such as Ehler Danlos syndrome, Pseudoxanthoma Elasticum, will be excluded from the study due to their inherent collagen defects and consequently on the incidence of palatal fistulas.
- •Children with Veau class I cleft palates and those who will need/needed any surgical technique other then Furlow palatoplasty will be excluded from the study.
结局指标
主要结局
Fistula Formation
时间窗: Within 1 year of surgery
Number of patients who developed post palatoplasty fistula
次要结局
- Number of Participants With Wound Infection(Within 1 year of surgery)
研究者
Mirko S. Gilardino
Director, Plastic Surgery Residency Program, Assistant Professor of Surgery
McGill University Health Centre/Research Institute of the McGill University Health Centre