To compare the incidence of seroma formation with or without local application of tranexamic acid in ventral herioplasty -a randomized control trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Reduction in Seroma formation is measured in test group (using tranexamic acid) than the control group ( using normal saline)
研究概览
简要总结
The main objective of this study is to find out reduction in seroma formation with local application of tranexamic acid before skin closure in ventral hernioplasty . Two groups A and B were randomized and one group receives local application of tranexamic acid before skin closure and in other group skin is closed without application of tranexamic acid. the drain output volume ion the following postoperative days were monitored and the output of fifth postoperative day is compared between two groups . The outcome of seroma reduction using tranexamic acid will be evaluated and if there is significant decrease in seroma formation using tranexamic acid it mat be used in large ventral hernia to prevent seroma and further complication such as infection, wound gapping following seroma formation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient having ventral hernia aged between 18 years to 80 years are included in the study.
- •Both male and female genders are included.
- •Hernial Defect size more than 2cms.
- •patient who are able to understand the merits and demerits.
排除标准
- •Patient having ventral hernia aged less than 16 years and above 80 years are excluded from the study.
- •Cirrhosis Uncontrolled Diabetes Mellitus, chronic kidney disease not willing to participate in the trial BMI more than 35 recurrence, Strangulated hernia, pregnancy patient with severe anaemia.
结局指标
主要结局
Reduction in Seroma formation is measured in test group (using tranexamic acid) than the control group ( using normal saline)
时间窗: daily drain output till day 5 of postoperative period is estimated and compared with control group
次要结局
- reduction of seroma formation using application of tranexamic acid compared with normal saline(first 5 days of post operative period)
研究者
Janani Devi Colon
Sri manakula vinayagar medical college and hospital, puducherry