Clinical trial NCT01969448: Study to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction
Official title: A Prospective Randomized Trial to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ductal Carcinoma in Situ - Category
Breast Cancer
Prophylactic Mastectomy
Keywords: Nipple-areola skin sparing mastectomy
Immediate reconstruction
Prophylactic Mastectomy
Breast-Q
Breast Cancer
Ductal Carcinoma in Situ - Category
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: LifeCell
First posted: 2013-10-25
Enrollment: 79
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that nipple-areola skin sparing mastectomy (NASSM) performed through an inframammary incision has a superior blood supply relative to a lateral oblique incision. Moreover, by minimizing complications and optimizing aesthetic outcomes, the investigators believe it will be associated with significantly higher patient reported outcome scores. The addition of information gained by use of intraoperative laser-assisted fluorescent angiography (measured with the Spy Elite imaging device) will reduce complication rates by directing intraoperative resection of ischemic tissue and limiting the volume of immediate implant placement in instances where real time imaging would suggest compromised perfusion. These quantifiable, objective measures will justify the use of NASSM and immediate implant placement coupled with intraoperative laser-assisted fluorescent angiography in prosthetic based breast reconstruction despite longer operative times.


Eligibility criteria: Inclusion Criteria:

* Patient must be scheduled to undergo either a single or bilateral elective nipple-areola skin sparing mastectomy (NASSM) procedure with planned immediate reconstruction.
* Patient must be 18 years of age or older.
* Karnofsky Performance Scale of at least 80%.
* Patient must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

* Cognitive impairment.
* BMI \< 18 or \> 35
* Breast \>800 grams or \<100 grams in predicted weight. "Breast" includes the breast tissue and in cases where the patient already has cosmetic breast implants, the additional breast implant mass. The sum total must be \>100 g and \<800 g.
* History of radiation to the chest wall or breast being studied
* Patients who have a history of allergy to iodides or iodinated contrast agents
* Surgeon's opinion at the time of surgery that the subject's well-being would be compromised (e.g. significant comorbidities, intraoperative findings of a higher stage cancer or other independent acute health problems). If the contralateral breast is undergoing a nipple-sparing mastectomy with reconstruction as well, then the contralateral breast can be studied so long as there is no compromise to any element of their care.

Primary outcomes:
measure: Percentage of Original Preoperative Blood Supply (Perfusion) Post Nipple Sparing Mastectomy
timeFrame: At the time of surgery (day 1)
measure: Percentage of Original Preoperative Blood Supply (Perfusion) Post Reconstruction
timeFrame: At the time of surgery (day 1)
Secondary outcomes:
measure: Breast Q Score
timeFrame: Up to 3 months post permanent implant placement
measure: Number of Participants With Tissue Expander
timeFrame: Up to 3 months post permanent implant placement
measure: Mean Operative Times for Mastectomy
timeFrame: At the time of surgery (day 1)
measure: Breast Weight
timeFrame: At time of surgery (day 1)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Marissa J Tenenbaum, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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