Localization of Intercostal Perforating Vessels Reduces Wound Complications From Nipple Sparing Mastectomy

January 13, 2021 updated by: Robert Maganini, MD, Amita Health

Ultrasound Localization of Intercostal Perforating Vessels Reduces Post-Operative Wound Complications From Nipple Sparing Mastectomy

Approximately 100 women scheduled for NSM will be consented pre-operatively to participate in the study. US will be performed after induction of general anesthesia, prior to surgery using Sonosite™ portable US, 5-12mHz transducer using doppler mode.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Nipple Sparing Mastectomy (NSM) has been increasingly utilized over the last ten years for risk-reducing surgery and surgical treatment for breast cancer. The oncologic safety has been well established in multiple studies in appropriately selected individuals. Additionally, rates of wound complications and risk factors for wound problems are well documented. The intercostal perforating vessels (IPV) have been demonstrated to provide a significant proportion of the blood supply to the nipple-areolar complex1-3. Thus, preservation of these vessels is essential to reducing ischemic necrosis of the nipple-areolar complex. We propose that localization of these vessels utilizing intra-operative ultrasound (US) will reduce ischemic necrosis complications of NSM.

Objectives

  • Demonstrate that US is an effective means of localizing the IPV intraoperatively.
  • Evaluate the frequency of IPV preservation with the use of US.
  • Measure rate and severity of ischemic necrosis when US is utilized to preserve IPV.
  • Compare observed rate with historical controls.

Study Type

Observational

Enrollment (Actual)

100

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
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • AMITA Health Alexian Brothers Medical Center

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Female subjects scheduled for nipple sparing mastectomy.

Description

Inclusion Criteria:

  • Females 18 years of age or older
  • Planned nipple sparing mastectomy

Exclusion Criteria:

  • Contraindication to nipple sparing mastectomy

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Localization of the intercostal perforating vessels utilizing intra-operative ultrasound (US) will reduce ischemic necrosis complications of nipple sparing mastectomy.
Time Frame: At the time of procedure
At the time of procedure

Collaborators and Investigators

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

Sponsor

Amita Health

Investigators

  • Principal Investigator: Robert O Maganini, MD, AMITA Health

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

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

October 1, 2016

Primary Completion (Actual)

December 1, 2020

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

October 18, 2016

First Submitted That Met QC Criteria

October 18, 2016

First Posted (Estimate)

October 19, 2016

Study Record Updates

Last Update Posted (Actual)

January 14, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Nipple Sparing Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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.

Subscribe