Trial Outcomes & Findings for Study to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction (NCT NCT01969448)

Results Overview

* 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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

79 participants

Primary outcome timeframe

At the time of surgery (day 1)

Results posted on

2018-04-18

Participant Flow

Enrollment to the study opened to enrollment 03/28/2013 and closed to enrollment on 03/09/2016.

Participant milestones

Participant milestones
Measure	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)	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)
Overall Study STARTED	55	24
Overall Study COMPLETED	55	24
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Inframammary Fold Incision Cohort n=55 Participants * 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)	Lateral Radial Incision Cohort n=24 Participants * 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)	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)	Total n=79 Participants Total of all reporting groups
Age, Continuous	43.2 years STANDARD_DEVIATION 10.8 • n=5 Participants	46.6 years STANDARD_DEVIATION 10.5 • n=7 Participants	—	44.2 years STANDARD_DEVIATION 10.7 • n=4 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	24 Participants n=7 Participants	0 Participants n=5 Participants	79 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	55 participants n=5 Participants	24 participants n=7 Participants	—	79 participants n=4 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Inframammary Fold Incision Cohort n=55 Participants * 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)	Lateral Radial Incision Cohort n=24 Participants * 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)	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)
Percentage of Original Preoperative Blood Supply (Perfusion) Post Nipple Sparing Mastectomy Overall breast	63.9 percentage of original preop perfusion	60.8 percentage of original preop perfusion	—
Percentage of Original Preoperative Blood Supply (Perfusion) Post Nipple Sparing Mastectomy Nipple	29.9 percentage of original preop perfusion	40.0 percentage of original preop perfusion	—
Percentage of Original Preoperative Blood Supply (Perfusion) Post Nipple Sparing Mastectomy Inferior	54.6 percentage of original preop perfusion	72.0 percentage of original preop perfusion	—
Percentage of Original Preoperative Blood Supply (Perfusion) Post Nipple Sparing Mastectomy Lateral	73.5 percentage of original preop perfusion	76.5 percentage of original preop perfusion	—
Percentage of Original Preoperative Blood Supply (Perfusion) Post Nipple Sparing Mastectomy Medial	62.5 percentage of original preop perfusion	65.2 percentage of original preop perfusion	—

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Inframammary Fold Incision Cohort n=55 Participants * 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)	Lateral Radial Incision Cohort n=24 Participants * 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)	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)
Percentage of Original Preoperative Blood Supply (Perfusion) Post Reconstruction Overall breast	30.6 percentage of original preop perfusion	35.1 percentage of original preop perfusion	—
Percentage of Original Preoperative Blood Supply (Perfusion) Post Reconstruction Nipple	23.2 percentage of original preop perfusion	31.3 percentage of original preop perfusion	—
Percentage of Original Preoperative Blood Supply (Perfusion) Post Reconstruction Inferior	21.9 percentage of original preop perfusion	36.9 percentage of original preop perfusion	—
Percentage of Original Preoperative Blood Supply (Perfusion) Post Reconstruction Lateral	23.01 percentage of original preop perfusion	40.7 percentage of original preop perfusion	—
Percentage of Original Preoperative Blood Supply (Perfusion) Post Reconstruction Medial	28.0 percentage of original preop perfusion	32.1 percentage of original preop perfusion	—

SECONDARY outcome

Timeframe: Up to 3 months post permanent implant placement

Population: 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.

-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.

Outcome measures

Outcome measures
Measure	Inframammary Fold Incision Cohort n=49 Participants * 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)	Lateral Radial Incision Cohort n=22 Participants * 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)	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)
Breast Q Score Satisfaction with Breasts (post-op)	69.3 units on a scale Standard Deviation 21.8	68.7 units on a scale Standard Deviation 12.0	—
Breast Q Score Satisfaction with Breasts (pre-op)	62.1 units on a scale Standard Deviation 17.3	53.8 units on a scale Standard Deviation 13.1	—
Breast Q Score Psychosocial (pre-op)	74.1 units on a scale Standard Deviation 16.5	68.0 units on a scale Standard Deviation 12.9	—
Breast Q Score Psychosocial (post-op)	79.8 units on a scale Standard Deviation 19.8	85.2 units on a scale Standard Deviation 17.0	—
Breast Q Score Physical chest (pre-op)	88.3 units on a scale Standard Deviation 14.0	85.7 units on a scale Standard Deviation 12.2	—
Breast Q Score Physical chest (post-op)	77.9 units on a scale Standard Deviation 12.4	83.4 units on a scale Standard Deviation 12.4	—
Breast Q Score Sexuality (pre-op)	59.4 units on a scale Standard Deviation 10.3	56.7 units on a scale Standard Deviation 10.8	—
Breast Q Score Sexuality (post-op)	68.7 units on a scale Standard Deviation 25.3	68.6 units on a scale Standard Deviation 17.2	—

SECONDARY outcome

Timeframe: Up to 3 months post permanent implant placement

Outcome measures

Outcome measures
Measure	Inframammary Fold Incision Cohort n=55 Participants * 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)	Lateral Radial Incision Cohort n=24 Participants * 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)	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)
Number of Participants With Tissue Expander	19 Participants	12 Participants	—

SECONDARY outcome

Timeframe: At the time of surgery (day 1)

Outcome measures

Outcome measures
Measure	Inframammary Fold Incision Cohort n=55 Participants * 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)	Lateral Radial Incision Cohort n=24 Participants * 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)	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)
Mean Operative Times for Mastectomy	155.3 minutes Standard Deviation 41.2	177.0 minutes Standard Deviation 29.0	—

SECONDARY outcome

Timeframe: At time of surgery (day 1)

Outcome measures

Outcome measures
Measure	Inframammary Fold Incision Cohort n=55 Participants * 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)	Lateral Radial Incision Cohort n=24 Participants * 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)	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)
Breast Weight	350 grams Standard Deviation 156	418 grams Standard Deviation 151	—

Adverse Events

Inframammary Fold Incision Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lateral Radial Incision Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-Randomized Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marissa J. Tenebaum, M.D.

Washington University School of Medicine

Phone: 314-996-8800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place