Split Chest Breast Neurotization

Sponsor

NYU Langone Health (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05757778

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Implant; Complications	Procedure: Sensory Nerve Coaptation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

Within patients, treatment with neurotization to one breast will be randomly assigned intra-operatively. Patients will remain blinded from intraoperative details until the completion of the study. Patients will consent to remain blinded to the operative and postoperative reports until completion of the study.

Primary Purpose:

Treatment

Official Title:

A Single-Blind, Split-Chest, Single-Center Study of the Effects of Breast Neurotization in Implant Based Breast Reconstruction

Anticipated Study Start Date :

Mar 15, 2023

Anticipated Primary Completion Date :

Mar 15, 2026

Anticipated Study Completion Date :

Mar 15, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Neurotized Breast For patients undergoing bilateral implant-based breast reconstruction following nipple-sparing mastectomy, one breast will be neurotized by connecting the lateral intercostal nerve to the nipple with interposing standard nerve grafting techniques. The neurotized breast will serve as the "experimental" breast. The other breast will not receive any breast neurotizing procedure.	Procedure: Sensory Nerve Coaptation 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.
No Intervention: Non-Neurotized Breast For patients undergoing bilateral implant-based breast reconstruction following nipple-sparing mastectomy, one breast will not receive any breast neurotizing procedure. The non-neurotized breast will serve as the "control" breast.

Arm

Intervention/Treatment

Experimental: Neurotized Breast

For patients undergoing bilateral implant-based breast reconstruction following nipple-sparing mastectomy, one breast will be neurotized by connecting the lateral intercostal nerve to the nipple with interposing standard nerve grafting techniques. The neurotized breast will serve as the "experimental" breast. The other breast will not receive any breast neurotizing procedure.

Procedure: Sensory Nerve Coaptation

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.

No Intervention: Non-Neurotized Breast

For patients undergoing bilateral implant-based breast reconstruction following nipple-sparing mastectomy, one breast will not receive any breast neurotizing procedure. The non-neurotized breast will serve as the "control" breast.

Outcome Measures

Primary Outcome Measures

Semmes-Weinstein Monofilament Testing (SWMT) Score in the Nipple (Area 9) [Month 12 Post-Surgery]
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.
SWMT Score in the Nipple (Area 9) [Month 24 Post-Surgery]
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.

Secondary Outcome Measures

SWMT Score in the Mastectomy Superior (Area 1) [Month 12 Post-Surgery]
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.
SWMT Score in the Mastectomy Superior (Area 1) [Month 24 Post-Surgery]
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.
SWMT Score in the Mastectomy Lateral (Area 2) [Month 12 Post-Surgery]
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.
SWMT Score in the Mastectomy Lateral (Area 2) [Month 24 Post-Surgery]
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.
SWMT Score in the Mastectomy Inferior (Area 3) [Month 12 Post-Surgery]
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.
SWMT Score in the Mastectomy Inferior (Area 3) [Month 24 Post-Surgery]
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.
SWMT Score in the Mastectomy Medial (Area 4) [Month 12 Post-Surgery]
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.
SWMT Score in the Mastectomy Medial (Area 4) [Month 24 Post-Surgery]
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.
SWMT Score in the Flap Superior (Area 5) [Month 12 Post-Surgery]
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.
SWMT Score in the Flap Superior (Area 5) [Month 24 Post-Surgery]
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.
SWMT Score in the Flap Lateral (Area 6) [Month 12 Post-Surgery]
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.
SWMT Score in the Flap Lateral (Area 6) [Month 24 Post-Surgery]
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.
SWMT Score in the Flap Inferior (Area 7) [Month 12 Post-Surgery]
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.
SWMT Score in the Flap Inferior (Area 7) [Month 24 Post-Surgery]
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.
SWMT Score in the Flap Medial (Area 8) [Month 12 Post-Surgery]
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.
SWMT Score in the Flap Medial (Area 8) [Month 24 Post-Surgery]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Health	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health

Investigators

Principal Investigator: Mihye Choi, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT05757778

Other Study ID Numbers:

22-01026

First Posted:

Mar 7, 2023

Last Update Posted:

Mar 8, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 8, 2023