Umbilicoplasty: A Randomized Controlled Trial of Techniques for Umbilical Reconstruction Following Abdominoplasty and Abdominally-based Free Tissue Transfer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in measurement of patient assessment post-operative and pre-operative, using a VAS survey results with a positive result indicating a favorable outcome
研究概览
简要总结
The primary objective of the study will be to determine which of five traditionally used umbilical reconstructive techniques offers superior aesthetic results. Additionally, secondary objectives of post-operative complications such as hypertrophic scar formation will also be measured.
详细描述
This is a five arm, prospective, randomized, trial. Patients undergoing abdominoplasty or abdominally-based free tissue transfer (TRAM/DIEP flaps) at NYU Medical Center will be randomly assigned to receive one of five conventionally used umbilicoplasty techniques during the course of their surgery:
- Round procedure
- "Scarless" round procedure
- "Inverted u" procedure
- "Inverted v" procedure, and
- "Y deepithelialized" procedure
As there has not yet been a superiority or inferiority comparison of these five methods, no patient will be receiving substandard care by randomization to one of the five procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent Form
- •Female patients undergoing abdominoplasty or abdominally-based free tissue transfer (TRAM/DIEP flaps)
排除标准
- •Patients with prior history of umbilicoplasty
- •History of keloid formation
- •Active smokers
- •Body Mass Index (BMI) over 40
结局指标
主要结局
Change in measurement of patient assessment post-operative and pre-operative, using a VAS survey results with a positive result indicating a favorable outcome
时间窗: Baseline, 12 Weeks
Assessment of inter-rater reliability among physicians in the assessment of the aesthetic outcomes of umbilical reconstruction.
时间窗: 12 Weeks
Comparison of aesthetic outcomes of umbilical reconstruction using five accepted techniques for umbilicoplasty following abdominoplasty or abdominally-based free tissue transfer (TRAM/DIEP flaps).
时间窗: 12 Weeks
次要结局
未报告次要终点