Localization of Intercostal Perforating Vessels Reduces Wound Complications From Nipple Sparing Mastectomy
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 2/14/2019 |
| Start Date: | October 2016 |
| End Date: | October 2019 |
| Contact: | Robert O Maganini, MD |
| Email: | robert.maganini@amitahealth.org |
| Phone: | 847-755-8700 |
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.
the study. US will be performed after induction of general anesthesia, prior to surgery using
Sonosite™ portable US, 5-12mHz transducer using doppler mode.
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.
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.
Inclusion Criteria:
- Females 18 years of age or older
- Planned nipple sparing mastectomy
Exclusion Criteria:
- Contraindication to nipple sparing mastectomy
We found this trial at
1
site
Elk Grove Village, Illinois 60007
Principal Investigator: Robert O Maganini, MD
Phone: 847-755-8700
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