NCT01796977终止不适用
A Prospective, Multi-Center, Randomized, Open Label Controlled Trial Using a Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 13
- 主要终点
- Evaluate the Effects of OxyGenesys Dissolved Oxygen Dressing in Wound Complication Rates of the Nipple Areolar Complex Post Nipple-sparing Mastectomy
研究概览
简要总结
This study will evaluate the effect of OxyGenesys Dissolved Oxygen Dressing in wound complication rates of the nipple areolar complex after a nipple sparing mastectomy.
详细描述
This study will recruit women who are undergoing a bilateral mastectomy for either cancer or a positive BRCA gene. Women will be randomized to a different treatment per breast. One breast will receive the OxyGenesys dressing and the other will receive the standard gauze dressing. The study will evaluate wound complication rates and compare the two treatments.
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is able to give written consent
- •Females >21 years of age
- •At least one breast diagnosed with cancer or mastectomy due to a positive BRCA gene mutation test.
- •Subject is indicated for bilateral nipple-sparing mastectomy surgery with immediate breast reconstruction
- •Subject is able to comply with the study protocol
排除标准
- •Primary tumor(s) located within 2cm of the areola margins
- •Inability to perform follow up assessments
- •Radiation treatment within 30 days of surgery
- •Dermabond or other forms of surgical glue is used in the peri-areola region
- •Subjects who are known to be allergic to any of the test product(s) or any component of the test product(s)
- •Women who are pregnant
- •Subjects who have been treated with an investigational drug or device within the past 30 days prior to enrollment
结局指标
主要结局
Evaluate the Effects of OxyGenesys Dissolved Oxygen Dressing in Wound Complication Rates of the Nipple Areolar Complex Post Nipple-sparing Mastectomy
时间窗: 30 days
Wound Complication Rate
次要结局
- To Assess Pain Using the Numerical Rating Scale(30 days)
- To Evaluate Scar Formation 30 Days Post Nipple-sparing Mastectomy(30 days post nipple-sparing mastectomy)
研究者
研究点 (13)
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