Nipple Reinnervation in Two-stage Alloplastic Breast Reconstruction.

A prospective study was conducted including patients undergoing nipple-sparing mastectomy with neurotization during expander-to-implant exchange between 2021 and 2025.

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Key information

Conditions

Breast Reconstruction

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Angeles Pedregal

Mexico City, 10700, Mexico

About this study

The investigators conducted a prospective study including consecutive patients undergoing nipple-sparing mastectomy (NSM) with nipple neurotization at the time of expander-to-implant exchange between 2021 and 2025.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult female patients (≥18 years of age).
Patients who underwent nipple-sparing mastectomy (NSM) with immediate tissue-expander placement.
Patients undergoing nipple neurotization at the time of expander-to-implant exchange.
Patients with a clinically viable nipple-areola complex (NAC) at the time of neurotization.
Patients who underwent standardized sensory assessment of the breast/NAC preoperatively and at least one postoperative time point.
Patients who provided informed consent for participation and postoperative sensory assessment.

Exclusion criteria

Patients younger than 18 years of age.
Male patients.
Patients who underwent a mastectomy other than nipple-sparing mastectomy.
Patients who underwent nipple neurotization at a time other than the expander-to-implant exchange.
Patients unable to undergo standardized sensory testing or unable to reliably report sensory perception.
Patients without adequate postoperative follow-up to perform the required sensory assessments.
Patients who declined participation or withdrew consent.

Treatment and study plan

Nipple neurotization

Procedure

Nipple neurotization

Primary outcomes

Sensory evaluation was performed in each zone using the British Medical Research Council (BMRC) scale

Time frame: 1 year

Sensory recovery will be assessed using the British Medical Research Council Sensory Scale, which grades sensory function from S0 to S4. S0 represents complete absence of sensation, while S4 represents normal sensation. The scale includes intermediate grades (S1, S2, S2+, S3, and S3+) reflecting progressive recovery of pain, tactile sensation, and two-point discrimination. The minimum value is S0 and the maximum value is S4; higher scores indicate better sensory recovery.
Sensory evaluation was performed in each zone using the Semmes-Weinstein monofilament test.

Time frame: 1 year

Sensory function will be assessed using Semmes-Weinstein monofilament testing with the Baseline Tactile Monofilament Test Kit, consisting of monofilaments calibrated to apply forces of 0.07 g, 0.4 g, 2.0 g, 4.0 g, and 300 g. The lowest force detected by the participant will be recorded as the sensory threshold. A lower detection threshold indicates better sensory function, with 0.07 g representing the best possible result and failure to detect the 300 g monofilament representing the worst possible result.

Sponsors and collaborators

Lead sponsor

Hospital Angeles del Pedregal

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2025
First posted: Aug 17, 2026
Registry last updated: Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed