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Nipple Reinnervation in Two-stage Alloplastic Breast Reconstruction.

Nipple Reinnervation in Two-stage Alloplastic Breast Reconstruction.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07767838
Enrollment
18
Registered
2026-08-17
Start date
2021-01-01
Completion date
2025-12-30
Last updated
2026-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Reconstruction

Keywords

Breast reconstruction

Brief summary

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

Detailed description

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.

Interventions

PROCEDURENipple neurotization

Nipple neurotization

Sponsors

Hospital Angeles del Pedregal
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Sensory evaluation was performed in each zone using the British Medical Research Council (BMRC) scale1 yearSensory 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.1 yearSensory 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.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 18, 2026