- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02938390
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Illinois
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Elk Grove Village, Illinois, United States, 60007
- AMITA Health Alexian Brothers Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Females 18 years of age or older
- Planned nipple sparing mastectomy
Exclusion Criteria:
- Contraindication to nipple sparing mastectomy
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Localization of the intercostal perforating vessels utilizing intra-operative ultrasound (US) will reduce ischemic necrosis complications of nipple sparing mastectomy.
Time Frame: At the time of procedure
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At the time of procedure
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert O Maganini, MD, AMITA Health
Publications and helpful links
General Publications
- Lemaine V, Hoskin TL, Farley DR, Grant CS, Boughey JC, Torstenson TA, Jacobson SR, Jakub JW, Degnim AC. Introducing the SKIN score: a validated scoring system to assess severity of mastectomy skin flap necrosis. Ann Surg Oncol. 2015 Sep;22(9):2925-32. doi: 10.1245/s10434-015-4409-3. Epub 2015 Jan 30.
- Palmer JH, Taylor GI. The vascular territories of the anterior chest wall. Br J Plast Surg. 1986 Jul;39(3):287-99. doi: 10.1016/0007-1226(86)90037-8.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Nipple Sparing Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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