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

NCT01969448 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2018-04-18

Study results available
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Summary

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.

Conditions

  • Ductal Carcinoma in Situ - Category
  • Breast Cancer
  • Prophylactic Mastectomy

Interventions

PROCEDURE

Inframammary Fold Incision or Lateral Radial Incision

PROCEDURE

Lateral Radial Incision

PROCEDURE

Inframammary Fold Incision

DEVICE

Laser-assisted fluorescence angiography

DRUG

Indocyanine Green

Sponsors & Collaborators

  • LifeCell

    collaborator INDUSTRY

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Marissa J Tenenbaum, M.D. · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-28
Primary Completion
2016-04-27
Completion
2017-04-17
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01969448 on ClinicalTrials.gov