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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02938390

Enrollment

100

Registered

2016-10-19

Start date

2016-10-31

Completion date

2021-12-31

Last updated

2021-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Nipple Sparing Mastectomy, Ultrasound

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.

Interventions

PROCEDUREUltrasound for localizing intercostal perforating vessels

Use of an Intra-operative ultrasound during nipple sparing mastectomy to localize intercostal perforating vessels.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Contraindication to nipple sparing mastectomy

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026