An interventional study of Autologous Breast Reconstruction With Direct Neurotization and Autologous Breast Reconstruction without Neurotization in Breast Reconstruction After Mastectomy, Neurotization and Mastectomy and Breast Reconstruction, sponsored by Fakultas Kedokteran Universitas Indonesia. Not yet recruiting at 1 site in Indonesia. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-29.
Sponsored by Fakultas Kedokteran Universitas Indonesia · Not applicable, Interventional, and Treatment
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:
As secondary objectives, the study will assess whether biological predictors of nerve regeneration correlate with sensory outcomes. These include:
Participants will be randomly assigned to receive either:
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:
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.
Fakultas Kedokteran Universitas Indonesia is the lead sponsor of 36 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
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.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Participants assigned to this arm are women undergoing mastectomy who are eligible for standard autologous breast reconstruction without neurotization.
Procedure: Autologous Breast Reconstruction without Neurotization
Participants assigned to this arm are women undergoing mastectomy who are eligible for autologous breast reconstruction with planned direct neurotization using fully autologous components.
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
Breast reconstruction is performed using autologous tissue without nerve coaptation or neurotization, according to standard surgical practice.
Breast Sensation assessed by using Semmes-Weinstein Monofilament testing
SWM thresholds at nine standardized points on the reconstructed breast will be measured using calibrated monofilaments, categorized into levels of normal touch, diminished light touch, diminished protective sensation, loss of protective sensation, and deep pressure only.
Time frame: 1, 3 and 6 months after Neurotization
Patient's Quality of Life assessed by using BREAST-Q® Sensation Module
The patient reported outcomes will be recorded in BREAST-Q® Sensation Module to capture the sensation, breast symptoms, and quality of life impact of sensation loss.
Time frame: 1, 3 and 6 months after Neurotization
Neuregulin 1 Expression
NRG1 expression quantified by ELISA from flap tissue
Time frame: During procedure and 6 months after surgery
Nerve Cross-sectional Area
Nerve cross-sectional area measured via histomorphometry/histopathology using the recipient nerve of the direct neurotization method
Time frame: Measured during neurotization procedure
Breast Morphometry
Breast morphometry assessed using a validated AR/3D application
Time frame: Before surgery and 1, 3, 6 months after surgery
Intraepidermal Nerve Fibre Density (IENFD)
IENFD quantified by counting PGP9.5-positive intraepidermal fibers per mm of epidermal length. Flap skin tissue samples will be taken using 3 mm punch biopsy
Time frame: During procedure and 6 months after surgery
Plan to share: No — Individual participant data will not be shared due to concerns regarding participant confidentiality and the potential risk of re-identification in a small surgical trial with detailed clinical and biomarker data.
Start is estimated for Dec 2025; primary completion for Feb 2027, 14 months later.
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This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Fakultas Kedokteran Universitas Indonesia