Breast Cancer Clinical Trial

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

Summary

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.

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Full 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.

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Eligibility Criteria

Inclusion Criteria:

Females 18 years of age or older
Planned nipple sparing mastectomy

Exclusion Criteria:

Contraindication to nipple sparing mastectomy

Study is for people with:

Breast Cancer

Estimated Enrollment:

100

Study ID:

NCT02938390

Recruitment Status:

Active, not recruiting

Sponsor:

Amita Health

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There is 1 Location for this study

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

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

100

Study ID:

NCT02938390

Recruitment Status:

Active, not recruiting

Sponsor:


Amita Health

How clear is this clinincal trial information?

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