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

• Conditions: Breast Cancer

• Registration Number: NCT02938390
• Lead Sponsor: Amita Health

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-18
• Study First Submitted QC: 2016-10-18
• Study First Posted: 2016-10-19
• Primary Completion: 2020-12
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-13
• Last Update Posted: 2021-01-14
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• Contraindication to nipple sparing mastectomy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

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