Role of topical nitroglycerin in the prevention and treatment of post mastectomy skin flap necrosis- a prospective comparative study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 1. Incidence of post mastectomy skin flap necrosis in patients using topical nitroglycerin
研究概览
简要总结
Aim to study the role of topical nitroglycerin in reducing the incidence of post mastectomy skin flap necrosis and in the treatment of the same Written and Informed consent will be obtained from all subjects before enrollment in the study
A group of 90 patients will be randomized in to group A and group B of 45 each
Group A will receive topical nitroglycerin tds for 6 days and group B will receive placebo for the same period
patients will be followed up at weekly intervals for 4 weeks
During each follow up visit the patient will be assessed for wound margin discolouration
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- Female
入选标准
- •Patients undergoing mastectomy.
排除标准
- •History of thromboembolic events Coronary artery disease patients Uncontrolled comorbidities History of hypersensitivity reactions.
结局指标
主要结局
1. Incidence of post mastectomy skin flap necrosis in patients using topical nitroglycerin
时间窗: 4 weeks
次要结局
- Role of topical nitroglycerin in treating post mastectomy skin flap necrosis by preventing the progression of necrosis & reducing the need for wound debridement whe compared to povidone iodine(4 weeks)
研究者
Dr Sumaiya Fathima
Govt Stanley Medical College
