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

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ClinicalTrials.gov Identifier: NCT02938390
Recruitment Status : Recruiting
First Posted : October 19, 2016
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Robert Maganini, MD, 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.

Condition or disease Intervention/treatment
Breast Cancer Procedure: Ultrasound for localizing intercostal perforating vessels

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Ultrasound Localization of Intercostal Perforating Vessels Reduces Post-Operative Wound Complications From Nipple Sparing Mastectomy
Study Start Date : October 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Ultrasound for localizing intercostal perforating vessels
    Use of an Intra-operative ultrasound during nipple sparing mastectomy to localize intercostal perforating vessels.


Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Female subjects scheduled for nipple sparing mastectomy.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindication to nipple sparing mastectomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938390


Contacts
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Contact: Robert O Maganini, MD 847-755-8700 robert.maganini@amitahealth.org
Contact: Drashti Shah 847.755-8349 Drashti.Shah@amitahealth.org

Locations
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United States, Illinois
AMITA Health Alexian Brothers Medical Center Recruiting
Elk Grove Village, Illinois, United States, 60007
Contact: Robert O Maganini, MD    847-755-8700    robert.maganini@amitahealth.org   
Contact: Drashti Shah    847.755-8349    Drashti.Shah@amitahealth.org   
Principal Investigator: Robert O Maganini, MD         
Sponsors and Collaborators
Amita Health
Investigators
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Principal Investigator: Robert O Maganini, MD Amita Health

Publications:
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Responsible Party: Robert Maganini, MD, Principal Investigator, Amita Health
ClinicalTrials.gov Identifier: NCT02938390     History of Changes
Other Study ID Numbers: Nipple Sparing Study
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Robert Maganini, MD, Amita Health:
Nipple Sparing Mastectomy
Ultrasound