Randomized Clinical Trial Comparing Silver Nitrate Application With Topical Corticosteroids for Hypergranulation Tissue at Gastrostomy Sites
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Maximal reduction in granulation tissue
研究概览
简要总结
This protocol describes a randomized, two arm clinical trial comparing two topical treatments in patients with hypergranulation tissue at gastrostomy tube sites. The subjects are randomized to either group 1or group 2 treatments:
Maximum duration of therapy is 4 weeks. However, the therapy may be discontinued anytime at the discretion of the investigator or if there is resolution of the of the hypergranulation tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients <18
- •Evaluated for hypergranulation at the G-tube site
- •Inpatient and out-patient
排除标准
- •Children not meeting the above criteia
研究组 & 干预措施
Group 1
Silver nitrate treatment will include weekly applications in the pediatric surgery office by a clinician.
干预措施: Silver Nitrate (Drug)
Group 2
Triamcinolone cream, 0.5% applied three times per day by the patient's caregiver.
干预措施: Triamcinolone (Drug)
结局指标
主要结局
Maximal reduction in granulation tissue
时间窗: During maximum of 4 weeks of therapy
次要结局
未报告次要终点
研究者
Eloise Lemon
Principal Investigator
Akron Children's Hospital