NCT07308275

Longitudinal Evaluation of Direct Neurotization Technique in Breast Reconstruction With Fully Autologous Components

Longitudinal Evaluation of Direct Neurotization Technique in Breast Reconstruction With Fully Autologous Components: An Assessment of BREAST-Q Sensation Module, Cutaneous Pressure Threshold, Neuregulin 1 (NRG1) Expression, Nerve Fiber Cross-sectional Area, Intraepidermal Nerve Fiber Density (IENFD), and Breast Morphometry

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Fakultas Kedokteran Universitas Indonesia · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial aims to evaluate whether direct neurotization using fully autologous components during autologous breast reconstruction improves postoperative breast sensation and sensory-related quality of life in women undergoing unilateral mastectomy. Direct neurotization involves coapting the recipient intercostal nerve to an autologous nerve graft placed within the flap to facilitate reinnervation. The study's primary questions are: 1. Does direct neurotization using fully autologous nerve grafts improve cutaneous sensory recovery, as assessed by Semmes-Weinstein monofilament thresholds measured at standardized breast locations? 2. Does neurotization enhance patient-reported sensory outcomes and quality of life, as assessed by the BREAST-Q Sensation Module? As secondary objectives, the study will assess whether biological predictors of nerve regeneration correlate with sensory outcomes. These include: 1. Neuregulin-1 (NRG1) expression in flap tissue biopsy; 2. Cross-sectional area of the recipient nerve fibres; 3. Breast morphometry measured at baseline and follow-up; 4. Intraepidermal nerve fibre density (IENFD) on skin biopsy. Participants will be randomly assigned to receive either: 1. Neurotized autologous breast reconstruction using fully autologous graft components, or 2. Standard (non-neurotized) autologous breast reconstruction. The study will compare these groups to determine whether neurotization accelerates or enhances the return of breast sensation over a 6-month follow-up period, with evaluations at 1 month, 3 months, and 6 months after surgery. Participants will undergo: 1. Autologous breast reconstruction with or without direct neurotization as part of their planned cancer surgery. 2. Sensory testing using Semmes-Weinstein monofilaments at baseline, 1, 3, and 6 months. 3. Completion of BREAST-Q questionnaires evaluating breast sensation, symptoms, and quality of life at each follow-up visit. 3\. Intraoperative tissue sampling for NRG1 analysis and nerve morphometry. 4. Skin biopsy (if applicable) to assess intraepidermal nerve fibre density. 5. Breast morphometry assessment using a breast morphometry measurement software tool. This study seeks to provide high-quality evidence on the effectiveness of direct neurotization using fully autologous components in restoring breast sensation and to explore biological predictors that may influence sensory recovery after autologous breast reconstruction.

Conditions

• Breast Reconstruction After Mastectomy
• Neurotization
• Mastectomy and Breast Reconstruction
• Peripheral Nerve Regeneration
• Sensory Function
• Quality of Life (QOL)

Interventions

Type	Name	Description
PROCEDURE	Autologous Breast Reconstruction With Direct Neurotization	The direct neurotization using fully autologous components procedures include: 1. Direct neurotization is carried out using fully autologous components, involving coaptation of the recipient nerve to an autologous nerve graft placed within the flap to facilitate reinnervation. 2. Surgical breast reconstruction is then completed using patient's own tissue
PROCEDURE	Autologous Breast Reconstruction without Neurotization	Breast reconstruction is performed using autologous tissue without nerve coaptation or neurotization, according to standard surgical practice.

Timeline

• Start date: 2025-12-15
• Primary completion: 2027-02-15
• Completion: 2027-04-15
• First posted: 2025-12-29
• Last updated: 2025-12-29

Locations

1 site across 1 country: Indonesia