Efficacy of a Novel Prototype Gastrostomy Tube Anchor Dressing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Rates Gastrostomy Tube Dislodgement Before and After Dressing Placement
研究概览
简要总结
This is a single-center prospective study evaluating the efficacy of a prototype gastrostomy anchor dressing for use with button gastrostomy tubes. The anchor dressing has been previously evaluated for usability by parents, patients, and nurses. This study compares several outcomes related to complications from gastrostomy tube placement using a prospective cohort of patients and a retrospective analysis of complications associated with gastrostomy tubes. Prospective patients will initially be monitored until they have completed their last dressing change or for a maximum of 50 days. They will then complete their final survey. Their charts will be reviewed for up to one year from their initial gastrostomy placement. The study's primary objective is to determine if the novel gastrostomy tube anchor dressing reduces rates of gastrostomy tube dislodgement and ED/clinic visits for gastrostomy tube complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 21 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are undergoing gastrostomy tube placement or are within five days post-operatively of gastrostomy tube placement.
排除标准
- •Patients with a skin condition that limits the placement of the dressing, this will be confirmed with the clinical team
结局指标
主要结局
Rates Gastrostomy Tube Dislodgement Before and After Dressing Placement
时间窗: Up to one year
Current rates of gastrostomy tube complications and dislodgement will be evaluated with our retrospective review, then compared to rates of complications and dislodgement after our novel dressing placement. This was chosen as complications after gastrostomy tube placement are high, and we believe that our dressing will lower them.
Gastrostomy tube complications
时间窗: Up to one year
次要结局
未报告次要终点
