Clinical trial NCT02938390: Localization of Intercostal Perforating Vessels Reduces Wound Complications From Nipple Sparing Mastectomy
Official title: Ultrasound Localization of Intercostal Perforating Vessels Reduces Post-Operative Wound Complications From Nipple Sparing Mastectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Nipple Sparing Mastectomy
Ultrasound
Lead sponsor: Amita Health
Sponsor class: OTHER
First posted: 2016-10-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female subjects scheduled for nipple sparing mastectomy.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Contraindication to nipple sparing mastectomy

Primary outcomes:
measure: Localization of the intercostal perforating vessels utilizing intra-operative ultrasound (US) will reduce ischemic necrosis complications of nipple sparing mastectomy.
timeFrame: At the time of procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Elk Grove Village
country: United States
facility: AMITA Health Alexian Brothers Medical Center
state: Illinois
Study officials:
affiliation: Amita Health
name: Robert O Maganini, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.