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临床试验/CTRI/2024/04/065465
CTRI/2024/04/065465尚未招募不适用

Role of topical nitroglycerin in the prevention and treatment of post mastectomy skin flap necrosis- a prospective comparative study

Govt Stanley medical college1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年4月30日最近更新:

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

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Sumaiya Fathima

Govt Stanley Medical College

研究点 (1)

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