A Single-Blind, Split-Chest, Single-Center Study of the Effects of Breast Neurotization in Implant Based Breast Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Semmes-Weinstein Monofilament Testing (SWMT) Score in the Nipple (Area 9)
研究概览
简要总结
Several members of the scientific community have suggested that breast neurotization can help return nipple sensation to patients undergoing implant-based breast reconstruction. There has been no randomized controlled study assessing the validity of these claims. The goal of this study is to evaluate if performing breast neurotization can help restore or improve return of nipple sensation to patients undergoing implant-based breast reconstruction. This will be a single-blinded, randomized controlled trial where patients undergoing bilateral reconstruction will serve as their own controls by receiving an intervention on one breast but not the other breast.
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
Within patients, treatment with neurotization to one breast will be randomly assigned intra-operatively. Patients will remain blinded from intraoperative details until the completion of the study. Patients will consent to remain blinded to the operative and postoperative reports until completion of the study.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing bilateral nipple-sparing mastectomy (prophylactic or therapeutic) at a single institution
- •Women receiving implant-based reconstruction (either direct to implant or tissue expander-based implant reconstruction of any size)
- •Age 18 or older
排除标准
- •Women with history of prior breast surgery given concern for potentially damaged nerves by prior intervention that could impact the procedure and results. Procedures include but are not limited to: prior breast reduction, prior breast augmentation, prior lumpectomy
- •Pre-operative radiation or anticipated post-operative radiation
- •Body Mass Index (BMI) > 30 kg/m2 or patients with macromastia (larger breasts) as these patients frequently require larger implants that will not accommodate the longest nerve graft available (70 mm)
- •Current tobacco or nicotine use
- •History of diabetes mellites with a HgbA1c > 7% due to lower rates of wound healing
- •History of auto-immune disease
- •History of allergy, sensitivity, or intolerance to porcine-derived materials
- •Intraoperatively, patients may have to be excluded if during the mastectomy the lateral nerve targets were severely damaged or removed as part of the mastectomy. While these patients will be excluded from the formal analysis, the investigators will continue to follow them as a subgroup for analysis and comparison.
- •Men as they infrequently receive bilateral mastectomies due to breast cancer. Male breast cancer is <1% of all breast malignancies.
- •Pregnancy as determined by urine pregnancy test on day of surgery
研究组 & 干预措施
Neurotized Breast
For patients undergoing bilateral implant-based breast reconstruction following nipple-sparing mastectomy, one breast will be neurotized by connecting the lateral intercostal nerve to the nipple with interposing standard nerve grafting techniques. The neurotized breast will serve as the "experimental" breast. The other breast will not receive any breast neurotizing procedure.
干预措施: Sensory Nerve Coaptation (Procedure)
Non-Neurotized Breast
For patients undergoing bilateral implant-based breast reconstruction following nipple-sparing mastectomy, one breast will not receive any breast neurotizing procedure. The non-neurotized breast will serve as the "control" breast.
结局指标
主要结局
Semmes-Weinstein Monofilament Testing (SWMT) Score in the Nipple (Area 9)
时间窗: Month 12 Post-Surgery
SWMT will be used for assessment of breast sensation by applying the monofilament to a given anatomic region. Based on the monofilament size, a score of 0-6 is assigned. Scores are classified as follows: 6 = normal; 5 = diminished light touch; 4 = diminished protective sensation; 3 = loss of protective sensation; 2 = Loss of protective/sensation; 1 = Deep pressure sensation only; and 0 = Loss of sensation.
SWMT Score in the Nipple (Area 9)
时间窗: Month 24 Post-Surgery
SWMT will be used for assessment of breast sensation by applying the monofilament to a given anatomic region. Based on the monofilament size, a score of 0-6 is assigned. Scores are classified as follows: 6 = normal; 5 = diminished light touch; 4 = diminished protective sensation; 3 = loss of protective sensation; 2 = Loss of protective/sensation; 1 = Deep pressure sensation only; and 0 = Loss of sensation.
次要结局
- SWMT Score in the Mastectomy Superior (Area 1)(Month 24 Post-Surgery)
- SWMT Score in the Flap Superior (Area 5)(Month 24 Post-Surgery)
- SWMT Score in the Mastectomy Medial (Area 4)(Month 24 Post-Surgery)
- SWMT Score in the Flap Lateral (Area 6)(Month 24 Post-Surgery)
- SWMT Score in the Mastectomy Lateral (Area 2)(Month 24 Post-Surgery)
- SWMT Score in the Mastectomy Inferior (Area 3)(Month 24 Post-Surgery)
- SWMT Score in the Flap Inferior (Area 7)(Month 24 Post-Surgery)
- SWMT Score in the Flap Medial (Area 8)(Month 24 Post-Surgery)
- SWMT Score in the Mastectomy Superior (Area 1)(Month 12 Post-Surgery)
- SWMT Score in the Mastectomy Lateral (Area 2)(Month 12 Post-Surgery)
- SWMT Score in the Mastectomy Inferior (Area 3)(Month 12 Post-Surgery)
- SWMT Score in the Mastectomy Medial (Area 4)(Month 12 Post-Surgery)
- SWMT Score in the Flap Superior (Area 5)(Month 12 Post-Surgery)
- SWMT Score in the Flap Lateral (Area 6)(Month 12 Post-Surgery)
- SWMT Score in the Flap Inferior (Area 7)(Month 12 Post-Surgery)
- SWMT Score in the Flap Medial (Area 8)(Month 12 Post-Surgery)