A Prospective Randomized Trial to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Percentage of Original Preoperative Blood Supply (Perfusion) Post Nipple Sparing Mastectomy
研究概览
简要总结
The investigators hypothesize that nipple-areola skin sparing mastectomy (NASSM) performed through an inframammary incision has a superior blood supply relative to a lateral oblique incision. Moreover, by minimizing complications and optimizing aesthetic outcomes, the investigators believe it will be associated with significantly higher patient reported outcome scores. The addition of information gained by use of intraoperative laser-assisted fluorescent angiography (measured with the Spy Elite imaging device) will reduce complication rates by directing intraoperative resection of ischemic tissue and limiting the volume of immediate implant placement in instances where real time imaging would suggest compromised perfusion. These quantifiable, objective measures will justify the use of NASSM and immediate implant placement coupled with intraoperative laser-assisted fluorescent angiography in prosthetic based breast reconstruction despite longer operative times.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient must be scheduled to undergo either a single or bilateral elective nipple-areola skin sparing mastectomy (NASSM) procedure with planned immediate reconstruction.
- •Patient must be 18 years of age or older.
- •Karnofsky Performance Scale of at least 80%.
- •Patient must be able to understand and willing to sign a written informed consent document.
排除标准
- •Cognitive impairment.
- •BMI < 18 or > 35
- •Breast >800 grams or <100 grams in predicted weight. "Breast" includes the breast tissue and in cases where the patient already has cosmetic breast implants, the additional breast implant mass. The sum total must be >100 g and <800 g.
- •History of radiation to the chest wall or breast being studied
- •Patients who have a history of allergy to iodides or iodinated contrast agents
- •Surgeon's opinion at the time of surgery that the subject's well-being would be compromised (e.g. significant comorbidities, intraoperative findings of a higher stage cancer or other independent acute health problems). If the contralateral breast is undergoing a nipple-sparing mastectomy with reconstruction as well, then the contralateral breast can be studied so long as there is no compromise to any element of their care.
研究组 & 干预措施
Inframammary Fold Incision Cohort
-
Inframammary fold incision which is in the crease under the breast.
-
Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)
-
Intraoperatively prior to mastectomy
-
At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet)
-
Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)
干预措施: Inframammary Fold Incision (Procedure)
Inframammary Fold Incision Cohort
-
Inframammary fold incision which is in the crease under the breast.
-
Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)
-
Intraoperatively prior to mastectomy
-
At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet)
-
Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)
干预措施: Laser-assisted fluorescence angiography (Device)
Inframammary Fold Incision Cohort
-
Inframammary fold incision which is in the crease under the breast.
-
Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)
-
Intraoperatively prior to mastectomy
-
At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet)
-
Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)
干预措施: Indocyanine Green (Drug)
Lateral Radial Incision Cohort
-
Lateral radial incision
-
Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)
-
Intraoperatively prior to mastectomy
-
At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet)
-
Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)
干预措施: Lateral Radial Incision (Procedure)
Lateral Radial Incision Cohort
-
Lateral radial incision
-
Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)
-
Intraoperatively prior to mastectomy
-
At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet)
-
Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)
干预措施: Laser-assisted fluorescence angiography (Device)
Lateral Radial Incision Cohort
-
Lateral radial incision
-
Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)
-
Intraoperatively prior to mastectomy
-
At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet)
-
Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)
干预措施: Indocyanine Green (Drug)
Non-Randomized Cohort
-
Patients in which the surgeon feels that for oncologic reasons must have a specific incision (either inframammary fold or lateral radial incision) and cannot be randomized due to concerns of compromising clinical care but otherwise meet the inclusion and exclusion criteria will be offered participation as part of a non-randomized cohort.
-
Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)
-
Intraoperatively prior to mastectomy
-
At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet)
-
Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)
干预措施: Inframammary Fold Incision or Lateral Radial Incision (Procedure)
Non-Randomized Cohort
-
Patients in which the surgeon feels that for oncologic reasons must have a specific incision (either inframammary fold or lateral radial incision) and cannot be randomized due to concerns of compromising clinical care but otherwise meet the inclusion and exclusion criteria will be offered participation as part of a non-randomized cohort.
-
Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)
-
Intraoperatively prior to mastectomy
-
At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet)
-
Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)
干预措施: Laser-assisted fluorescence angiography (Device)
Non-Randomized Cohort
-
Patients in which the surgeon feels that for oncologic reasons must have a specific incision (either inframammary fold or lateral radial incision) and cannot be randomized due to concerns of compromising clinical care but otherwise meet the inclusion and exclusion criteria will be offered participation as part of a non-randomized cohort.
-
Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell)
-
Intraoperatively prior to mastectomy
-
At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet)
-
Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)
干预措施: Indocyanine Green (Drug)
结局指标
主要结局
Percentage of Original Preoperative Blood Supply (Perfusion) Post Nipple Sparing Mastectomy
时间窗: At the time of surgery (day 1)
* Laser-assisted fluorescent angiography via the Spy Elite imaging device will be utilized to capture this data during mastectomy and immediate breast reconstruction. Standard postoperative patient follow up will assess for perfusion. * The Spy device quantifies perfusion by measuring relative fluorescence of indocyanine green bound to plasma proteins. This produces an intensity value of 0-255 based on an 8-bit greyscale. The investigators measured this value preoperatively when measured and compared to the post-intervention measurement. The device can calculate the cumulative intensity of a defined region of interest which the investigators categorized as the lateral, lower, medial, or nipple-areola region of the breast. The investigators also evaluated the cumulative value of these areas in total. Rate of perfusion was simply this value over time (90 seconds).
Percentage of Original Preoperative Blood Supply (Perfusion) Post Reconstruction
时间窗: At the time of surgery (day 1)
* Laser-assisted fluorescent angiography via the Spy Elite imaging device will be utilized to capture this data during mastectomy and immediate breast reconstruction. Standard postoperative patient follow up will assess for perfusion. * The Spy device quantifies perfusion by measuring relative fluorescence of indocyanine green bound to plasma proteins. This produces an intensity value of 0-255 based on an 8-bit greyscale. The investigators measured this value preoperatively when measured and compared to the post-intervention measurement. The device can calculate the cumulative intensity of a defined region of interest which the investigators categorized as the lateral, lower, medial, or nipple-areola region of the breast. The investigators also evaluated the cumulative value of these areas in total. Rate of perfusion was simply this value over time (90 seconds).
次要结局
- Breast Weight(At time of surgery (day 1))
- Breast Q Score(Up to 3 months post permanent implant placement)
- Number of Participants With Tissue Expander(Up to 3 months post permanent implant placement)
- Mean Operative Times for Mastectomy(At the time of surgery (day 1))