The Effect of Collagen Matrix Graft on Postoperative Palatal Fistula Formation After Cleft Palate Repair: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Number of participants with postoperative palatal fistula
研究概览
简要总结
Palatal fistulas are a major burden to surgeons and patients in the management of cleft palate. Their high rate of occurrence and recurrence makes them particularly challenging even to the highly skilled surgeon. Prevention of postoperative palatal fistula is therefore of paramount importance.
Closure of the nasal mucosa under tension has been proposed as a major cause of palatal fistula formation. However, depending on the presentation of the cleft palate, it may be impossible to achieve surgical closure with minimal tension. Till date, there is no universally acceptable method of preventing palatal fistula formation following cleft palate repair. And although the use of pre-surgical appliances such as Latham appliance and the use of local and distant tissues to achieve two layer closure have been proposed, the use of a superpositional collagen graft may also be used to achieve closure of the nasal mucosa with minimal or no tension during cleft palate repair.
Collagen grafts have the added advantage of being more patient friendly compared to the Latham appliance which requires an initial surgery for appliance insertion before surgical cleft palate repair. They are also less technique sensitive compared to the use of local and distant tissues.
The investigators therefore aim to provide high level scientific evidence of the effectiveness of collagen graft in the prevention of postoperative palatal fistula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
This study will be a double-blind randomized controlled study. After random allocation, the participants (parents/ patients) will be unaware of the study group they belong to. Also, the surgeon assessing postoperative outcomes will not perform the surgery and will be unaware of the study group of the participant being examined. Since the collagen graft will be placed between the nasal/ muscular layers and the oral layer, it is expected that after apposition of the oral layer, no collagen matrix will be visible intraorally to reveal the study group of participants.
入排标准
- 年龄范围
- 12 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-syndromic cleft palate
- •Must be between nine months to two years
- •Must have not previously had cleft palate surgery
- •Must consent to participate in the study
排除标准
- •All blood dyscrasias
- •All connective tissue dysfunctions
结局指标
主要结局
Number of participants with postoperative palatal fistula
时间窗: One month post operatively
Palatal fistula will be defined as a patency between the oral and nasal cavities developing postoperatively anywhere along the primary or secondary palate
次要结局
- Number of participants with wound dehiscence(One month post operatively)
- Number of participants with surgical site inflammation(One month post operatively)
- Number of participants with surgical site infection(One month post operatively)
- Surgeon satisfaction(within the first 24 hours post operatively)
研究者
Egbunah Uchenna Patrick
Senior Registrar
University of Lagos, Nigeria