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Spots Global Cancer Trial Database for Localization of Intercostal Perforating Vessels Reduces Wound Complications From Nipple Sparing Mastectomy

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Trial Identification

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

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

Study ID: NCT02938390

Conditions

Breast Cancer

Study Description

Brief 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.

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Robert O Maganini, MD

Affiliation: Amita Health

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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