Comparison of Double Ligation and Topical Silver Nitrate for Treatment of Umbilical Granuloma in Children: A Randomized Control Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 176
- 主要终点
- Frequency of Success/Failure of treatment
研究概览
简要总结
To study and compare the efficacy and safety of Double Ligation and Topical Silver Nitrate Solution while treating children with Umbilical Granulomas
详细描述
The patients underwent one treatment option and then followed up for three weeks and the results noted in terms of success/failure and complications specific to each treatment option and analysed accordingly
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 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of Umbilical Granuloma, less than 1 year age
排除标准
- •Patients who already had any treatment
- •Parents refused to give consent for enrollment
- •Patients lost in follow up
研究组 & 干预措施
Group 1
88 cases of umbilical granulomas who were treated with double ligation
干预措施: Double Ligation (Procedure)
Group 2
88 cases of umbilical granulomas who were treated with topical silver nitrate
干预措施: Topical Silver Nitrate (Drug)
结局指标
主要结局
Frequency of Success/Failure of treatment
时间窗: 3 weeks
The effect of treatment was noted in a structured proforma on weekly basis for 3 weeks. Treatment was considered successful if, on local examination the granuloma disappeared completely and did not reappear during the follow up period. And if the granuloma did not disppear completely during the follow up period after double ligation or application of silver nitrate, treatment was considered to have failed. These variables were measured as frequency and percentages. The results were compared between the two groups using chi-square test. A significance level of \<0.05 was considered significant.
Frequency of complications in both groups
时间窗: 3 weeks
The complications were also noted in the above mentioned proforma during the follow up period on weekly basis for 3 weeks. Complications relevant to the treatment i.e. infection, bleeding, chemical burns and skin discoloration were noted during local examination. These variables were measured as frequency and percentages. The results were compared between the two groups using chi-square test. A significance level of \<0.05 was considered significant
次要结局
未报告次要终点
研究者
Muhammad Rashid
Scholar MS Paediatric Surgery
Shaheed Zulfiqar Ali Bhutto Medical University