Longitudinal Evaluation of Direct Neurotization Technique in Breast Reconstruction With Fully Autologous Components
NCT ID: NCT07308275
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
28 participants
INTERVENTIONAL
2025-12-15
2027-04-15
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Non-Neurotized Group
Participants assigned to this arm are women undergoing mastectomy who are eligible for standard autologous breast reconstruction without neurotization.
Autologous Breast Reconstruction without Neurotization
Breast reconstruction is performed using autologous tissue without nerve coaptation or neurotization, according to standard surgical practice.
Neurotized Group
Participants assigned to this arm are women undergoing mastectomy who are eligible for autologous breast reconstruction with planned direct neurotization using fully autologous components.
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
Interventions
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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
Autologous Breast Reconstruction without Neurotization
Breast reconstruction is performed using autologous tissue without nerve coaptation or neurotization, according to standard surgical practice.
Eligibility Criteria
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Inclusion Criteria
* Patients with unilateral breast cancer who have undergone or will undergo unilateral mastectomy.
* Patients undergoing breast reconstruction.
* Patients with unilateral breast cancer regardless of adjuvant therapy status (receiving radiotherapy and/or chemotherapy or receiving no adjuvant therapy).
* Willing to comply with all scheduled examinations and tissue sampling procedures.
* Able and willing to provide written informed consent.
Exclusion Criteria
* Bilateral mastectomy.
* Presence of skin or soft-tissue conditions of the breast that may interfere with sensory assessment.
* Active smokers (use of tobacco, vape, or other nicotine products within 14 days prior to neurotization).
* Refusal or inability to attend follow-up evaluations.
18 Years
FEMALE
No
Sponsors
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Fakultas Kedokteran Universitas Indonesia
OTHER
Responsible Party
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Mohamad Rachadian Ramadan
dr. Mohamad Rachadian Ramadan, B.Med.Sc, Sp.B.P.R.E, Subsp.M.O.(K), MRBS
Locations
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dr. Ciptomangunkusumo National Hospital - Faculty of Medicine Universitas Indonesia
Jakarta Pusat, Jakarta Special Capital Region, Indonesia
Countries
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Central Contacts
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Facility Contacts
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Ayu PB Sarena, MD, MPH
Role: primary
References
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Bubberman JM, Brandts L, van Kuijk SMJ, van der Hulst RRWJ, Tuinder SMH. The efficacy of sensory nerve coaptation in DIEP flap breast reconstruction - Preliminary results of a double-blind randomized controlled trial. Breast. 2024 Apr;74:103691. doi: 10.1016/j.breast.2024.103691. Epub 2024 Feb 9.
Timar B, Popescu S, Timar R, Baderca F, Duica B, Vlad M, Levai C, Balinisteanu B, Simu M. The usefulness of quantifying intraepidermal nerve fibers density in the diagnostic of diabetic peripheral neuropathy: a cross-sectional study. Diabetol Metab Syndr. 2016 Apr 11;8:31. doi: 10.1186/s13098-016-0146-4. eCollection 2016.
Samolis A, Troupis T, Politis C, Pantazis N, Triantafyllou G, Tsakotos G, Tegos T, Lazaridis N, Natsis K, Piagkou M. Intraepidermal Nerve Fiber Density as an Indicator of Neuropathy Predisposition: A Systematic Review with Meta-Analysis. Diagnostics (Basel). 2025 May 23;15(11):1311. doi: 10.3390/diagnostics15111311.
La Padula S, Pensato R, D'Andrea F, de Gregorio L, Errico C, Rega U, Canta L, Pizza C, Roccaro G, Billon R, Dibra E, Meningaud JP, Hersant B. Assessment of Patient Satisfaction Using a New Augmented Reality Simulation Software for Breast Augmentation: A Prospective Study. J Clin Med. 2022 Jun 16;11(12):3464. doi: 10.3390/jcm11123464.
Song S, Parmeshwar N, Steiner G, Kim EA. Morphometric Analysis of Gender-affirming Breast Augmentation. Plast Reconstr Surg Glob Open. 2022 Nov 29;10(11):e4691. doi: 10.1097/GOX.0000000000004691. eCollection 2022 Nov.
Bin JM, Suminaite D, Benito-Kwiecinski SK, Kegel L, Rubio-Brotons M, Early JJ, Soong D, Livesey MR, Poole RJ, Lyons DA. Importin 13-dependent axon diameter growth regulates conduction speeds along myelinated CNS axons. Nat Commun. 2024 Feb 27;15(1):1790. doi: 10.1038/s41467-024-45908-6.
Clark IA, Mohammadi S, Callaghan MF, Maguire EA. Conduction velocity along a key white matter tract is associated with autobiographical memory recall ability. Elife. 2022 Sep 27;11:e79303. doi: 10.7554/eLife.79303.
Fricker FR, Lago N, Balarajah S, Tsantoulas C, Tanna S, Zhu N, Fageiry SK, Jenkins M, Garratt AN, Birchmeier C, Bennett DL. Axonally derived neuregulin-1 is required for remyelination and regeneration after nerve injury in adulthood. J Neurosci. 2011 Mar 2;31(9):3225-33. doi: 10.1523/JNEUROSCI.2568-10.2011.
Stassart RM, Fledrich R, Velanac V, Brinkmann BG, Schwab MH, Meijer D, Sereda MW, Nave KA. A role for Schwann cell-derived neuregulin-1 in remyelination. Nat Neurosci. 2013 Jan;16(1):48-54. doi: 10.1038/nn.3281. Epub 2012 Dec 9.
Dellon ES, Crone S, Mouery R, Dellon AL. Comparison of the Semmes-Weinstein monofilaments with the Pressure-Specifying Sensory Device. Restor Neurol Neurosci. 1993 Jan 1;5(5):323-6. doi: 10.3233/RNN-1993-55602.
Voineskos SH, Klassen AF, Cano SJ, Pusic AL, Gibbons CJ. Giving Meaning to Differences in BREAST-Q Scores: Minimal Important Difference for Breast Reconstruction Patients. Plast Reconstr Surg. 2020 Jan;145(1):11e-20e. doi: 10.1097/PRS.0000000000006317.
Gallo L, Chu JJ, Shamsunder MG, Hatchell A, Patel AR, Godwin K, Hernandez M, Pusic AL, Nelson JA, Voineskos SH. Best Practices for BREAST-Q Research: A Systematic Review of Study Methodology. Plast Reconstr Surg. 2022 Sep 1;150(3):526e-535e. doi: 10.1097/PRS.0000000000009401. Epub 2022 Jun 24.
Ramadan MR, Rifai DA, Atmodiwirjo P, Panigoro SS, Mukarramah DA, Sobri FB, Jurisman A, Djohan R. Indonesian Translation and Cultural Adaptation of the BREAST-Q Reconstruction Module. Plast Reconstr Surg Glob Open. 2025 Apr 21;13(4):e6705. doi: 10.1097/GOX.0000000000006705. eCollection 2025 Apr.
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
Shiah E, Laikhter E, Comer CD, Manstein SM, Bustos VP, Bain PA, Lee BT, Lin SJ. Neurotization in Innervated Breast Reconstruction: A Systematic Review of Techniques and Outcomes. J Plast Reconstr Aesthet Surg. 2022 Sep;75(9):2890-2913. doi: 10.1016/j.bjps.2022.06.006. Epub 2022 Jun 17.
Tecce MG, Desai AA, Christopher A, Cunning J, Rios-Diaz AJ, Morris MP, et al. 6. Breast Flap Neurotization After Autologous Free Flap Breast Reconstruction: A Prospective Trial. In: PRS Global Open [Internet]. 2022. Available from: http://journals.lww.com/prsgo
Shyu S, Chang TN, Lu JC, Chen CF, Cheong DC, Kao SW, Kuo WL, Huang JJ. Breast neurotization along with breast reconstruction after nipple sparing mastectomy enhances quality of life and reduces denervation symptoms in patient-reported outcome: a prospective cohort study. Int J Surg. 2025 May 1;111(5):3235-3247. doi: 10.1097/JS9.0000000000002331.
Jagasia PM, Bagdady K, Jordan SW, Howard MA, Fracol ME. Meta-analysis of Objective Sensory Outcomes From 764 Breasts Shows Superior Sensation of Autologous Reconstruction With Neurotization. Plast Reconstr Surg Glob Open. 2025 May 6;13(5):e6751. doi: 10.1097/GOX.0000000000006751. eCollection 2025 May.
Other Identifiers
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STUDINEUROTISASI
Identifier Type: -
Identifier Source: org_study_id