Study to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy with Immediate Reconstruction
This trial is active, not recruiting.
|Conditions||ductal carcinoma in situ - category, breast cancer, prophylactic mastectomy|
|Treatments||inframammary fold incision or lateral radial incision, lateral radial incision, inframammary fold incision, laser-assisted fluorescence angiography|
|Sponsor||Washington University School of Medicine|
|Start date||March 2013|
|End date||March 2017|
|Trial size||83 participants|
|Trial identifier||NCT01969448, 201302004|
The primary hypothesis of this study is to determine which of two incision sites (inframammary fold incision or the lateral radial incision) provides a more robust blood supply to the skin envelope during nipple-sparing mastectomy with immediate reconstruction.
Following education about the trial and informed consent, patients will be randomized to one of the two incisions. If their surgeon recommends a particular incision, there is also a non-randomized cohort. Patients will complete the Breast Q, a questionnaire prior to surgery and three months after surgery to capture quality of life data. During the surgery, laser-assisted fluorescent angiography will be performed three times to look at blood perfusion with the Spy Elite imaging device.
Patients will be required to return for postoperative follow up visits. All patients will be seen approximately one week, three weeks, and six weeks after surgery. Patients with a direct implant will finish the study at their three month post-operative visit. Patients with an expander will finish the study three months after their final implant is placed.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Robust blood supply to skin envelope during mastectomy and reconstruction
time frame: Up to 4 years.
Breast Q and Q-score
time frame: Up to 4 years.
Female participants at least 18 years old.
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. - Karnofsky Performance Scale of at least 80%. Exclusion Criteria: - BMI < 18 or > 35 - Breast tissue of > 800 grams or < 100 grams in weight - History of radiation to the chest wall or breast being studied - History of allergy to iodides or iodinated contrast agents - Cognitive impairment - 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).
|Official title||A Prospective Randomized Trial to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction|
|Principal investigator||Marissa J Tenenbaum, MD|
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