An interventional study of Nipple neurotization in Breast Reconstruction, sponsored by Hospital Angeles del Pedregal. Completed at 1 site in Mexico. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Hospital Angeles del Pedregal · Not applicable, Interventional, and Treatment
A prospective study was conducted including patients undergoing nipple-sparing mastectomy with neurotization during expander-to-implant exchange between 2021 and 2025.
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.
Hospital Angeles del Pedregal is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Nipple neurotization
Nipple neurotization
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.
Time frame: 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.
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2021 to primary completion in Dec 2025, 59 months.
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Hospital Angeles del Pedregal