Several members of the scientific community have suggested that breast neurotization can help return nipple sensation to patients undergoing implant-based breast reconstruction. There has been no randomized controlled study assessing the validity of these claims. The goal of this study is to evaluate if performing breast neurotization can help restore or improve return of nipple sensation to patients undergoing implant-based breast reconstruction. This will be a single-blinded, randomized controlled trial where patients undergoing bilateral reconstruction will serve as their own controls by receiving an intervention on one breast but not the other breast.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
6
Nerve reconstruction will employ an off-the-shelf nerve graft coapted to the donor anterior intercostal nerve branch laterally and medially at the underside of the nipple. The anterior intercostal nerve branch and nerve graft coaptation will be performed in a standard fashion with a 1 mm gap between the ends of the graft and the donor nerve. Medially, the nerve graft will be inset into the underside of the preserved nipple-areola complex using 8-0 or 9-0 epineural stitches from the nerve allograft. All nerve coaptations will be performed under loupe magnification as is standardly performed.
NYU Langone Health
New York, New York, United States
Semmes-Weinstein Monofilament Testing (SWMT) Score in the Nipple (Area 9)
SWMT will be used for assessment of breast sensation by applying the monofilament to a given anatomic region. Based on the monofilament size, a score of 0-6 is assigned. Scores are classified as follows: 6 = normal; 5 = diminished light touch; 4 = diminished protective sensation; 3 = loss of protective sensation; 2 = Loss of protective/sensation; 1 = Deep pressure sensation only; and 0 = Loss of sensation.
Time frame: Month 12 Post-Surgery
SWMT Score in the Nipple (Area 9)
SWMT will be used for assessment of breast sensation by applying the monofilament to a given anatomic region. Based on the monofilament size, a score of 0-6 is assigned. Scores are classified as follows: 6 = normal; 5 = diminished light touch; 4 = diminished protective sensation; 3 = loss of protective sensation; 2 = Loss of protective/sensation; 1 = Deep pressure sensation only; and 0 = Loss of sensation.
Time frame: Month 24 Post-Surgery
SWMT Score in the Mastectomy Superior (Area 1)
SWMT will be used for assessment of breast sensation by applying the monofilament to a given anatomic region. Based on the monofilament size, a score of 0-6 is assigned. Scores are classified as follows: 6 = normal; 5 = diminished light touch; 4 = diminished protective sensation; 3 = loss of protective sensation; 2 = Loss of protective/sensation; 1 = Deep pressure sensation only; and 0 = Loss of sensation.
Time frame: Month 12 Post-Surgery
SWMT Score in the Mastectomy Superior (Area 1)
SWMT will be used for assessment of breast sensation by applying the monofilament to a given anatomic region. Based on the monofilament size, a score of 0-6 is assigned. Scores are classified as follows: 6 = normal; 5 = diminished light touch; 4 = diminished protective sensation; 3 = loss of protective sensation; 2 = Loss of protective/sensation; 1 = Deep pressure sensation only; and 0 = Loss of sensation.
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Time frame: Month 24 Post-Surgery
SWMT Score in the Mastectomy Lateral (Area 2)
SWMT will be used for assessment of breast sensation by applying the monofilament to a given anatomic region. Based on the monofilament size, a score of 0-6 is assigned. Scores are classified as follows: 6 = normal; 5 = diminished light touch; 4 = diminished protective sensation; 3 = loss of protective sensation; 2 = Loss of protective/sensation; 1 = Deep pressure sensation only; and 0 = Loss of sensation.
Time frame: Month 12 Post-Surgery
SWMT Score in the Mastectomy Lateral (Area 2)
SWMT will be used for assessment of breast sensation by applying the monofilament to a given anatomic region. Based on the monofilament size, a score of 0-6 is assigned. Scores are classified as follows: 6 = normal; 5 = diminished light touch; 4 = diminished protective sensation; 3 = loss of protective sensation; 2 = Loss of protective/sensation; 1 = Deep pressure sensation only; and 0 = Loss of sensation.
Time frame: Month 24 Post-Surgery
SWMT Score in the Mastectomy Inferior (Area 3)
SWMT will be used for assessment of breast sensation by applying the monofilament to a given anatomic region. Based on the monofilament size, a score of 0-6 is assigned. Scores are classified as follows: 6 = normal; 5 = diminished light touch; 4 = diminished protective sensation; 3 = loss of protective sensation; 2 = Loss of protective/sensation; 1 = Deep pressure sensation only; and 0 = Loss of sensation.
Time frame: Month 12 Post-Surgery
SWMT Score in the Mastectomy Inferior (Area 3)
SWMT will be used for assessment of breast sensation by applying the monofilament to a given anatomic region. Based on the monofilament size, a score of 0-6 is assigned. Scores are classified as follows: 6 = normal; 5 = diminished light touch; 4 = diminished protective sensation; 3 = loss of protective sensation; 2 = Loss of protective/sensation; 1 = Deep pressure sensation only; and 0 = Loss of sensation.
Time frame: Month 24 Post-Surgery
SWMT Score in the Mastectomy Medial (Area 4)
SWMT will be used for assessment of breast sensation by applying the monofilament to a given anatomic region. Based on the monofilament size, a score of 0-6 is assigned. Scores are classified as follows: 6 = normal; 5 = diminished light touch; 4 = diminished protective sensation; 3 = loss of protective sensation; 2 = Loss of protective/sensation; 1 = Deep pressure sensation only; and 0 = Loss of sensation.
Time frame: Month 12 Post-Surgery
SWMT Score in the Mastectomy Medial (Area 4)
SWMT will be used for assessment of breast sensation by applying the monofilament to a given anatomic region. Based on the monofilament size, a score of 0-6 is assigned. Scores are classified as follows: 6 = normal; 5 = diminished light touch; 4 = diminished protective sensation; 3 = loss of protective sensation; 2 = Loss of protective/sensation; 1 = Deep pressure sensation only; and 0 = Loss of sensation.
Time frame: Month 24 Post-Surgery
SWMT Score in the Flap Superior (Area 5)
SWMT will be used for assessment of breast sensation by applying the monofilament to a given anatomic region. Based on the monofilament size, a score of 0-6 is assigned. Scores are classified as follows: 6 = normal; 5 = diminished light touch; 4 = diminished protective sensation; 3 = loss of protective sensation; 2 = Loss of protective/sensation; 1 = Deep pressure sensation only; and 0 = Loss of sensation.
Time frame: Month 12 Post-Surgery
SWMT Score in the Flap Superior (Area 5)
SWMT will be used for assessment of breast sensation by applying the monofilament to a given anatomic region. Based on the monofilament size, a score of 0-6 is assigned. Scores are classified as follows: 6 = normal; 5 = diminished light touch; 4 = diminished protective sensation; 3 = loss of protective sensation; 2 = Loss of protective/sensation; 1 = Deep pressure sensation only; and 0 = Loss of sensation.
Time frame: Month 24 Post-Surgery
SWMT Score in the Flap Lateral (Area 6)
SWMT will be used for assessment of breast sensation by applying the monofilament to a given anatomic region. Based on the monofilament size, a score of 0-6 is assigned. Scores are classified as follows: 6 = normal; 5 = diminished light touch; 4 = diminished protective sensation; 3 = loss of protective sensation; 2 = Loss of protective/sensation; 1 = Deep pressure sensation only; and 0 = Loss of sensation.
Time frame: Month 12 Post-Surgery
SWMT Score in the Flap Lateral (Area 6)
SWMT will be used for assessment of breast sensation by applying the monofilament to a given anatomic region. Based on the monofilament size, a score of 0-6 is assigned. Scores are classified as follows: 6 = normal; 5 = diminished light touch; 4 = diminished protective sensation; 3 = loss of protective sensation; 2 = Loss of protective/sensation; 1 = Deep pressure sensation only; and 0 = Loss of sensation.
Time frame: Month 24 Post-Surgery
SWMT Score in the Flap Inferior (Area 7)
SWMT will be used for assessment of breast sensation by applying the monofilament to a given anatomic region. Based on the monofilament size, a score of 0-6 is assigned. Scores are classified as follows: 6 = normal; 5 = diminished light touch; 4 = diminished protective sensation; 3 = loss of protective sensation; 2 = Loss of protective/sensation; 1 = Deep pressure sensation only; and 0 = Loss of sensation.
Time frame: Month 12 Post-Surgery
SWMT Score in the Flap Inferior (Area 7)
SWMT will be used for assessment of breast sensation by applying the monofilament to a given anatomic region. Based on the monofilament size, a score of 0-6 is assigned. Scores are classified as follows: 6 = normal; 5 = diminished light touch; 4 = diminished protective sensation; 3 = loss of protective sensation; 2 = Loss of protective/sensation; 1 = Deep pressure sensation only; and 0 = Loss of sensation.
Time frame: Month 24 Post-Surgery
SWMT Score in the Flap Medial (Area 8)
SWMT will be used for assessment of breast sensation by applying the monofilament to a given anatomic region. Based on the monofilament size, a score of 0-6 is assigned. Scores are classified as follows: 6 = normal; 5 = diminished light touch; 4 = diminished protective sensation; 3 = loss of protective sensation; 2 = Loss of protective/sensation; 1 = Deep pressure sensation only; and 0 = Loss of sensation.
Time frame: Month 12 Post-Surgery
SWMT Score in the Flap Medial (Area 8)
SWMT will be used for assessment of breast sensation by applying the monofilament to a given anatomic region. Based on the monofilament size, a score of 0-6 is assigned. Scores are classified as follows: 6 = normal; 5 = diminished light touch; 4 = diminished protective sensation; 3 = loss of protective sensation; 2 = Loss of protective/sensation; 1 = Deep pressure sensation only; and 0 = Loss of sensation.
Time frame: Month 24 Post-Surgery