Clinical trial NCT05757778: Split Chest Breast Neurotization
Official title: A Single-Blind, Split-Chest, Single-Center Study of the Effects of Breast Neurotization in Implant Based Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Implant; Complications
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Women undergoing bilateral nipple-sparing mastectomy (prophylactic or therapeutic) at a single institution
* Women receiving implant-based reconstruction (either direct to implant or tissue expander-based implant reconstruction of any size)
* Age 18 or older

Exclusion Criteria:

* Women with history of prior breast surgery given concern for potentially damaged nerves by prior intervention that could impact the procedure and results. Procedures include but are not limited to: prior breast reduction, prior breast augmentation, prior lumpectomy
* Pre-operative radiation or anticipated post-operative radiation
* Body Mass Index (BMI) \> 30 kg/m2 or patients with macromastia (larger breasts) as these patients frequently require larger implants that will not accommodate the longest nerve graft available (70 mm)
* Current tobacco or nicotine use
* History of diabetes mellites with a HgbA1c \> 7% due to lower rates of wound healing
* History of auto-immune disease
* History of allergy, sensitivity, or intolerance to porcine-derived materials
* Intraoperatively, patients may have to be excluded if during the mastectomy the lateral nerve targets were severely damaged or removed as part of the mastectomy. While these patients will be excluded from the formal analysis, the investigators will continue to follow them as a subgroup for analysis and comparison.
* Men as they infrequently receive bilateral mastectomies due to breast cancer. Male breast cancer is \<1% of all breast malignancies.
* Pregnancy as determined by urine pregnancy test on day of surgery

Primary outcomes:
measure: Semmes-Weinstein Monofilament Testing (SWMT) Score in the Nipple (Area 9)
timeFrame: Month 12 Post-Surgery
measure: SWMT Score in the Nipple (Area 9)
timeFrame: Month 24 Post-Surgery
Secondary outcomes:
measure: SWMT Score in the Mastectomy Superior (Area 1)
timeFrame: Month 12 Post-Surgery
measure: SWMT Score in the Mastectomy Superior (Area 1)
timeFrame: Month 24 Post-Surgery
measure: SWMT Score in the Mastectomy Lateral (Area 2)
timeFrame: Month 12 Post-Surgery
measure: SWMT Score in the Mastectomy Lateral (Area 2)
timeFrame: Month 24 Post-Surgery
measure: SWMT Score in the Mastectomy Inferior (Area 3)
timeFrame: Month 12 Post-Surgery
measure: SWMT Score in the Mastectomy Inferior (Area 3)
timeFrame: Month 24 Post-Surgery
measure: SWMT Score in the Mastectomy Medial (Area 4)
timeFrame: Month 12 Post-Surgery
measure: SWMT Score in the Mastectomy Medial (Area 4)
timeFrame: Month 24 Post-Surgery
measure: SWMT Score in the Flap Superior (Area 5)
timeFrame: Month 12 Post-Surgery
measure: SWMT Score in the Flap Superior (Area 5)
timeFrame: Month 24 Post-Surgery
measure: SWMT Score in the Flap Lateral (Area 6)
timeFrame: Month 12 Post-Surgery
measure: SWMT Score in the Flap Lateral (Area 6)
timeFrame: Month 24 Post-Surgery
measure: SWMT Score in the Flap Inferior (Area 7)
timeFrame: Month 12 Post-Surgery
measure: SWMT Score in the Flap Inferior (Area 7)
timeFrame: Month 24 Post-Surgery
measure: SWMT Score in the Flap Medial (Area 8)
timeFrame: Month 12 Post-Surgery
measure: SWMT Score in the Flap Medial (Area 8)
timeFrame: Month 24 Post-Surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Mihye Choi
role: PRINCIPAL_INVESTIGATOR
References: