Topical Nitroglycerin as a Mechanism for Cutaneous Vaso-modulation and Improved Wound Healing After Breast Reduction
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in Vancouver Scar Scoring (VSS)
研究概览
简要总结
The purpose of this study is evaluate the effect of Nitroglycerin paste on wound healing and scarring. Previous research has shown that Nitroglycerin paste can improve the blood flow to a wound, which may be associated with better wound healing, and ultimately, better scarring.
详细描述
This will be a single-center, patient-blinded, (breast) randomized trial utilizing nitroglycerin paste on their breast reduction scar. The study team aims to randomize 100 patients, or 200 breasts. Each patient will receive treatment, but the breast that received treatment will be random. This will allow for a control breast to compare to. Patients will be followed for 12 months postoperatively to observe wound healing.
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
- Double (Participant, Care Provider)
盲法说明
The patient will be masked and will not know which breast received the nitropaste. The investigator who applied nitropaste will know which breast was treated, but the investigator who conducts the follow-up visits will not.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who are female and transmen
- •Undergoing bilateral breast reduction via Mount Sinai Plastic Surgery Clinic
- •Reduction must be performed via Wise incisional pattern
排除标准
- •Patients who are male or transwomen
- •Patients who are under 18 years of age
研究组 & 干预措施
Dermabond
The control breast will receive Dermabond only
干预措施: Dermabond (Drug)
Nitroglycerine paste
The randomized breast will receive Nitroglycerine paste and Dermabond.
干预措施: Nitroglycerin Paste (Drug)
Nitroglycerine paste
The randomized breast will receive Nitroglycerine paste and Dermabond.
干预措施: Dermabond (Drug)
结局指标
主要结局
Change in Vancouver Scar Scoring (VSS)
时间窗: First post-op visit (0 weeks post op) and last visit at 12 months
Change in Vancouver Scar Scoring at 12 as compared to first post visit. VSS is a standardized scar appearance protocol - full score from 0-13, with higher score indicating poorer health outcomes.
次要结局
- Number of side-effects of Nitroglycerin use(12 months)
- Number of occurrences of wound breakdown(12 months)
研究者
Peter J. Taub
Professor
Icahn School of Medicine at Mount Sinai