Localization of Intercostal Perforating Vessels Reduces Wound Complications From Nipple Sparing Mastectomy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02938390|
Recruitment Status : Recruiting
First Posted : October 19, 2016
Last Update Posted : February 12, 2019
|Condition or disease||Intervention/treatment|
|Breast Cancer||Procedure: Ultrasound for localizing intercostal perforating vessels|
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.
- 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 :||Observational|
|Estimated Enrollment :||100 participants|
|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|
- Procedure: Ultrasound for localizing intercostal perforating vessels
Use of an Intra-operative ultrasound during nipple sparing mastectomy to localize intercostal perforating vessels.
- 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 ]
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
|Contact: Robert O Maganini, MDfirstname.lastname@example.org|
|Contact: Drashti Shah||847.755-8349||Drashti.Shah@amitahealth.org|
|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 email@example.com|
|Contact: Drashti Shah 847.755-8349 Drashti.Shah@amitahealth.org|
|Principal Investigator: Robert O Maganini, MD|
|Principal Investigator:||Robert O Maganini, MD||Amita Health|