Nipple Reinnervation in Two-stage Alloplastic Breast Reconstruction.

NCT07767838 | Completed DMC

• 1 other identifier: PI-20-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Reconstruction

Keywords

Breast reconstruction

Outcome Measures

Primary Outcomes (2)

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

  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.

  1 year

• Sensory evaluation was performed in each zone using the Semmes-Weinstein monofilament test.

  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.

  1 year

Study Arms (1)

Surgery

EXPERIMENTAL

Procedure: Nipple neurotization

Interventions

Nipple neurotization PROCEDURE

Nipple neurotization

Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Angeles del Pedregal: lead

Study Sites (1)

Hospital Angeles Pedregal

Mexico City, Mexico City, 10700, Mexico

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Plastic Surgeon

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 17, 2026
• Study Start: January 1, 2021
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)