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

March 20, 2018 updated by: Washington University School of Medicine

A Prospective Randomized Trial to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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)
Drug: Indocyanine Green
Procedure: Inframammary Fold Incision
Device: Laser-assisted fluorescence angiography
Other Names:
  • Spy Elite, LifeCell.
Active Comparator: 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)
Drug: Indocyanine Green
Device: Laser-assisted fluorescence angiography
Other Names:
  • Spy Elite, LifeCell.
Procedure: Lateral Radial Incision
Other: 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)
Drug: Indocyanine Green
Device: Laser-assisted fluorescence angiography
Other Names:
  • Spy Elite, LifeCell.
Procedure: Inframammary Fold Incision or Lateral Radial Incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Original Preoperative Blood Supply (Perfusion) Post Nipple Sparing Mastectomy
Time Frame: 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).
At the time of surgery (day 1)
Percentage of Original Preoperative Blood Supply (Perfusion) Post Reconstruction
Time Frame: 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).
At the time of surgery (day 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breast Q Score
Time Frame: Up to 3 months post permanent implant placement
-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.
Up to 3 months post permanent implant placement
Number of Participants With Tissue Expander
Time Frame: Up to 3 months post permanent implant placement
Up to 3 months post permanent implant placement
Mean Operative Times for Mastectomy
Time Frame: At the time of surgery (day 1)
At the time of surgery (day 1)
Breast Weight
Time Frame: At time of surgery (day 1)
At time of surgery (day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

LifeCell

Investigators

  • Principal Investigator: Marissa J Tenenbaum, M.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2013

Primary Completion (Actual)

April 27, 2016

Study Completion (Actual)

April 17, 2017

Study Registration Dates

First Submitted

October 14, 2013

First Submitted That Met QC Criteria

October 21, 2013

First Posted (Estimate)

October 25, 2013

Study Record Updates

Last Update Posted (Actual)

April 18, 2018

Last Update Submitted That Met QC Criteria

March 20, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201302004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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