Effect of Nitroglycerin Ointment on Mastectomy Flap Necrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 3
- 主要终点
- Mastectomy Flap Necrosis
研究概览
简要总结
Background:
Mastectomy flap necrosis (MFN) is a common complication that affects recovery, reconstructive success and aesthetic outcome. Nitroglycerin (NTG) ointment is a potent topical vasodilator that increases local blood flow by dilating arteries and veins without altering the ratio of pre- to post-capillary resistance. There are no studies that evaluate whether the application of NTG ointment in patients undergoing Skin-sparing mastectomy (SSM) or nipple-sparing mastectomy (NSM) and immediate reconstruction decreases the rate of mastectomy flap necrosis.
Objective:
To evaluate if the post-operative application of NTG ointment improve rates of MFN in patients undergoing SSM or NSM with immediate breast reconstruction compared to patients receiving placebo.
Hypothesis:
In patients undergoing SSM and immediate breast reconstruction there will be a decrease in the rate of MFN in those who receive NTG ointment compared to those who receive placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who undergo SSM or NSM with immediate alloplastic or autologous breast reconstruction
- •Unilateral and bilateral cases (in bilateral cases only the mastectomy performed by the general surgeon will be included. This will avoid the potential effect of absorption of nitroglycerin from one breast to the other)
- •Patients older than 21 and less than 65
排除标准
- •Patient declining inclusion in the study
- •Patient with medical history that precludes the administration of nitroglycerin, i.e. a medical history significant for
- •Acute circulatory failure accompanied by clear hypotension
- •Myocardial insufficiency related to obstruction
- •Use of sildenafil, vardenafil & tadalafil
- •Use of beta-blockers, calcium channel blockers, diuretics or phenothiazides
- •Salicylates (ASA)
- •Alteplase
- •Recent history of MI or cardiac insufficiency
- •Anemia, severe
- •Cerebral hemorrhage or recent head trauma
- •Hepatic function impairment, severe
- •Hyperthyroidism
- •Hypertrophic cardiomyopathy
- •Hypotension
- •Sensitivity to nitrites
- •Patient with a history of mantle radiation
- •Patient with an allergy to polysporin or any of its ingredients
研究组 & 干预措施
Polysporin Control
Patients in control group will receive polysporin ointment application. Polysporin ointment will be made to look like Nitroglycerin ointment.
干预措施: Polysporin ointment (Drug)
Nitroglycerin
Patients in treatment group will receive nitroglycerin ointment application
干预措施: nitroglycerin ointment (Drug)
结局指标
主要结局
Mastectomy Flap Necrosis
时间窗: 1 month post operative
次要结局
未报告次要终点