Nipple Reinnervation in Two-stage Alloplastic Breast Reconstruction.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Sensory evaluation was performed in each zone using the British Medical Research Council (BMRC) scale
研究概览
简要总结
A prospective study was conducted including patients undergoing nipple-sparing mastectomy with neurotization during expander-to-implant exchange between 2021 and 2025.
详细描述
The investigators conducted a prospective study including consecutive patients undergoing nipple-sparing mastectomy (NSM) with nipple neurotization at the time of expander-to-implant exchange between 2021 and 2025.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult female patients (≥18 years of age).
- •Patients who underwent nipple-sparing mastectomy (NSM) with immediate tissue-expander placement.
- •Patients undergoing nipple neurotization at the time of expander-to-implant exchange.
- •Patients with a clinically viable nipple-areola complex (NAC) at the time of neurotization.
- •Patients who underwent standardized sensory assessment of the breast/NAC preoperatively and at least one postoperative time point.
- •Patients who provided informed consent for participation and postoperative sensory assessment.
排除标准
- •Patients younger than 18 years of age.
- •Male patients.
- •Patients who underwent a mastectomy other than nipple-sparing mastectomy.
- •Patients who underwent nipple neurotization at a time other than the expander-to-implant exchange.
- •Patients unable to undergo standardized sensory testing or unable to reliably report sensory perception.
- •Patients without adequate postoperative follow-up to perform the required sensory assessments.
- •Patients who declined participation or withdrew consent.
研究组 & 干预措施
Surgery
干预措施: Nipple neurotization (Procedure)
结局指标
主要结局
Sensory evaluation was performed in each zone using the British Medical Research Council (BMRC) scale
时间窗: 1 year
Sensory recovery will be assessed using the British Medical Research Council Sensory Scale, which grades sensory function from S0 to S4. S0 represents complete absence of sensation, while S4 represents normal sensation. The scale includes intermediate grades (S1, S2, S2+, S3, and S3+) reflecting progressive recovery of pain, tactile sensation, and two-point discrimination. The minimum value is S0 and the maximum value is S4; higher scores indicate better sensory recovery.
Sensory evaluation was performed in each zone using the Semmes-Weinstein monofilament test.
时间窗: 1 year
Sensory function will be assessed using Semmes-Weinstein monofilament testing with the Baseline Tactile Monofilament Test Kit, consisting of monofilaments calibrated to apply forces of 0.07 g, 0.4 g, 2.0 g, 4.0 g, and 300 g. The lowest force detected by the participant will be recorded as the sensory threshold. A lower detection threshold indicates better sensory function, with 0.07 g representing the best possible result and failure to detect the 300 g monofilament representing the worst possible result.
次要结局
未报告次要终点
研究者
Jose Eduardo Telich Tarriba
Plastic Surgeon
Hospital Angeles del Pedregal