跳至主要内容
临床试验/NCT07115134
NCT07115134招募中不适用

Efficacy of a Novel Prototype Gastrostomy Tube Anchor Dressing

Children's National Research Institute2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年9月24日最近更新:

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

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

研究者

发起方
Children's National Research Institute
申办方类型
Other
责任方
Sponsor

研究点 (2)

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