| Primary | Percentage of Original Preoperative Blood Supply (Perfusion) Post Nipple Sparing Mastectomy |
- 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).
| | Posted | | Number | | percentage of original preop perfusion | | At the time of surgery (day 1) | | | | ID | Title | Description |
|---|
| OG000 | 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)
| | OG001 | Lateral Radial Incision Cohort | | | OG002 | 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)
|
| | | Title | Denominators | Categories |
|---|
| Overall breast | | | | Nipple | | |
| |
| Primary | Percentage of Original Preoperative Blood Supply (Perfusion) Post Reconstruction |
- 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).
| | Posted | | Number | | percentage of original preop perfusion | | At the time of surgery (day 1) | | | | ID | Title | Description |
|---|
| OG000 | 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)
|
|
| Secondary | Breast Q Score | -The BREAST-Q is a previously validated instrument which measures patient reported outcomes. It has several iterations including the one utilized here which is specific for implant-based breast reconstruction. Each of its 6 domains generates a Q-score from 0 (lowest) to 100 (highest). A higher number indicates a higher satisfaction or better quality of life than a lower number. Based on answers to the questions, each individual will generate a whole number score for each domain. The patient can be sampled preoperatively and postoperatively as well as over time to calculate the impact of intervention and time on this value. Q-scores are calculated for each domain, and the investigators report a mean value based on data from an entire cohort for the particular domain. Domains include evaluation of overall satisfaction with breasts, physical well being, sexual well being, as well as satisfaction with office staff, information provided, and the provider. | 6 participants were not evaluable for this outcome measure in the inframammary fold incision cohort and 2 particpants were not evaluable for this outcome measure in the lateral radial incision cohort due to not completing the Breast Q score. | Posted | | Mean | Standard Deviation | units on a scale | | Up to 3 months post permanent implant placement | | | | ID | Title | Description |
|---|
| OG000 | 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)
|
|
| Secondary | Number of Participants With Tissue Expander | | | Posted | | Count of Participants | | Participants | | Up to 3 months post permanent implant placement | | | | ID | Title | Description |
|---|
| OG000 | 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)
| | OG001 | Lateral Radial Incision Cohort | | | OG002 |
|
| Secondary | Mean Operative Times for Mastectomy | | | Posted | | Mean | Standard Deviation | minutes | | At the time of surgery (day 1) | | | | ID | Title | Description |
|---|
| OG000 | 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)
| | OG001 | Lateral Radial Incision Cohort | | | OG002 | Non-Randomized Cohort |
|
| Secondary | Breast Weight | | | Posted | | Mean | Standard Deviation | grams | | At time of surgery (day 1) | | | | ID | Title | Description |
|---|
| OG000 | 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)
| | OG001 | Lateral Radial Incision Cohort | | | OG002 | Non-Randomized Cohort |
|