NCT04818580终止不适用
A Prospective Cohort Study Comparing the Effect of Progressive Tension Sutures and Drains to Drains Alone on Rates of Hematoma and Seroma in Gender Affirming Mastectomy for Transgender Men
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Total volume of Drain Fluid
研究概览
简要总结
50 patients seeking gender affirming mastectomy will be treated with different closure techniques in each side of their chest - one side will receive progressive tension sutures between pectoral fascia and the mastectomy flap, and the other side will not. Both sides will have drains in the mastectomy site. Rates of hematoma, seroma, and other complications will be compared between each chest side via standard statistical techniques for hypothesis testing.
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
- Single (Participant)
盲法说明
A random number generator will be used. Subjects will be blinded as to which side of the chest has the sutures.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Being consulted for gender affirming mastectomy with the senior author (AH).
- •>18 years of age at the time of enrollment.
- •Transgender or gender nonbinary gender identity.
- •All co-morbidities and all indications.
排除标准
- •Age less than 18 years.
结局指标
主要结局
Total volume of Drain Fluid
时间窗: Visit 4, Day 30
Participants will record drain outputs each time they empty drains in the Postoperative Drain Output Record (mL)
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Study to Assess Outcomes in Women Undergoing Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal SterilizationContraceptionNCT03127722Bayer990
Unknown
4 期
Clinical Trial Comparing Outcomes of Breast Conserving Operations With Classic v High-frequency ElectrocoagulationBreast CancerNCT01216254Medical University of Gdansk150
已完成
3 期
Trial Comparing Electric and Harmonic Scalpel in MastectomyComplication, PostoperativeNCT01391988Barretos Cancer Hospital97
招募中
不适用
Efficacy of Angiography With Indocyanine Green in the Identification of Complications After Breast SurgerySkin NecrosisComplicationNCT05910931University Hospital A Coruña221
Unknown
不适用
Study of Clinic-based vs. Self-use of a Misoprostol-only Regimen for Induced AbortionFirst Trimester AbortionInduced AbortionNCT04242212Ipas4,000