Neurorrhaphy Only vs Neurorrhaphy Plus PRF vs Neurorrhaphy Plus Nano-fat in Management of Traumatic Facial Nerve Injury
NCT ID: NCT06977607
Last Updated: 2025-05-18
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
21 participants
INTERVENTIONAL
2024-10-01
2026-01-01
Brief Summary
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Detailed Description
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Traumatic facial nerve injury may account for up to 10% of the causes of facial nerve palsy and has devastating effects on patients both functionally, emotionally, and aesthetically.
The most common traumatic causes of facial paralysis are resection of tumors, temporal bone fractures, and penetrating trauma to the facial nerve, including iatrogenic injury.
Patients with Facial paralysis are at a higher risk of developing adverse psychological outcomes such as depression, anxiety, and disrupted social interaction.
Facial paralysis has implications for patients' quality of life due to the facial nerve's role in myriad activities of daily living.
Peripheral nerve injuries can result in significant morbidity, including motor and/or sensory loss, which can significantly affect the life of the patient. Nowadays, the gold standard for treating nerve sections is end-to-end neurorrhaphy. Unlike other tissues in the body, peripheral nerve regeneration is slow and usually incomplete. Despite current surgical techniques, less than half of the patients who undergo nerve repair after injury regain good to excellent motor or sensory function. Primary neurorrhaphy is the preferred reconstruction modality over nerve grafting, especially for motor nerves. The main limitation to primary repair is often dictated by tension secondary to increased nerve defect length.
If coaptation without tension is impossible, a cable graft interposition using the greater auricular or sural nerves may be necessary. The success rate of nerve repair, defined as a return to House-Brackmann grade III function or better, varies from 5% to 86% within the literature.
Several new neural repair technologies have been developed recently, such as nerve regeneration bridging technology, electrical stimulation technology, and stem cell therapy technology.
Nanofat is a relatively novel technique in fat grafting that has gained significant interest in regenerative medicine, aesthetics, and translational research. It involves the extraction of autologous fat from a patient, which is then transformed into "nanofat", consisting of small fat particles with a diameter of less than 0.1 mm and containing high concentrations of stem cells and growth factors.
Adipose-derived stem cells have a huge proliferative capacity and can differentiate into mesoderm, ectoderm, and endoderm lineages. Using nano-fat graft, a better quality and faster rate of new epithelium formation in the donor site is possible.
The use of platelets for regenerative medicine has increased in recent years. Platelets, which contain growth factors, play significant roles in cell migration, proliferation, differentiation, and angiogenesis and are associated with the tissue regeneration process.
The use of PRP has increased exponentially in tissue regeneration due to its high therapeutic potential in regenerative medicine. It has been shown that the concentration of platelets compared to basal levels improves the regenerative capacity of cells, tissues, and organs.
Platelet-rich concentrates are used as a source of growth factors to improve the healing process. The diverse preparation protocols and the gaps in knowledge of their biological properties complicate the interpretation of clinical results.
The centrifugation of venous blood produces autologous platelet concentrates (APCs) at different speeds, along with the use or non-use of thrombin and anticoagulants. The fibrin clot formed after this process contains platelets and leukocytes. There are several generations of APCs.
The use of stem cells is a medical biotechnology breakthrough, bringing regenerative therapy into a new era. Stem cells are effective therapeutic agents against several diseases due to their tissue protective and repair mechanisms.
The purpose of this clinical trial is to apply potential therapeutic methods for facial nerve regeneration for acute traumatic facial nerve injury Grade V according to Sunderland classification and compare the outcome of neurorrhaphy, a surgical technique for nerve repair, versus neurorrhaphy plus PRF versus neurorrhaphy plus NFSCs in improving traumatic facial nerve injuries.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
* A research Nurse will perform simple randomization before surgery using the closed-envelop technique.
* Twenty-one closed envelopes will be used; each 7 carries one of the three groups that will be randomly withdrawn at the time of surgery.
TREATMENT
NONE
Study Groups
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Platelets Rich Fibrin
Injection of PRF, which contains various growth factors, including GDNF and nerve growth factor (NGF), promotes peripheral nerve regeneration post-neurorrhaphy.
To compare the outcome of Neurorrhaphy Platelet-rich fibrin versus Neurorrhaphy alone and Neurorrhaphy with Nanofat.
Platelets Rich Fibrin
Repair of facial nerve injury plus Platelets Rich Fibrin will be injected around the repair and measure the out come in comparison with (Repair only) and (Repair Plus Nano-fat stem cells)
Repair only
Neurorrhaphy is the traditional method of surgical repair To compare the outcome of Neurorrhaphy alone Versus Using Different Adjuvants with Neurorrhaphy, such as Platelet-Rich Fibrin and Nano-fat.
Repair only
facial nerve neurorrhaphy only (repair only) after acute facial nerve trauma and measure the out come in comparison with (Repair plus Nano- fat Stem Cells) and (Repair Plus Platelets Rich Fibrin).
Nano-fat stem cells (NFSCs)
Injection of NFSCs contains abundant stromal vascular fraction cells and adipose-derived stem cells that help tissue regeneration. Post-neurorrhaphy injection contains abundant stromal cells that support tissue regeneration.
To compare the outcome of Neurorrhaphy with Nanofat-derived stem cells injection versus Neurorrhaphy with platelet-rich fibrin injection.
Nano-fat stem cells (NFSCs)
Repair of facial nerve injury plus Nano fat derived stem cells will be injected around the repair and measure the out come in comparison with (Repair only) and (Repair Plus Platelets Rich Fibrin).
Interventions
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Platelets Rich Fibrin
Repair of facial nerve injury plus Platelets Rich Fibrin will be injected around the repair and measure the out come in comparison with (Repair only) and (Repair Plus Nano-fat stem cells)
Nano-fat stem cells (NFSCs)
Repair of facial nerve injury plus Nano fat derived stem cells will be injected around the repair and measure the out come in comparison with (Repair only) and (Repair Plus Platelets Rich Fibrin).
Repair only
facial nerve neurorrhaphy only (repair only) after acute facial nerve trauma and measure the out come in comparison with (Repair plus Nano- fat Stem Cells) and (Repair Plus Platelets Rich Fibrin).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Grade V according to Sunderland classification.
Exclusion Criteria
* Steroid Dependent.
20 Years
50 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Doaa Mohie Selim
Specialist
Principal Investigators
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Doaa M. Selim, Specialist
Role: PRINCIPAL_INVESTIGATOR
University of Assiut
Locations
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Assiut University
Asyut, Asyut Governorate, Egypt
Countries
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References
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Mijiritsky E, Assaf HD, Peleg O, Shacham M, Cerroni L, Mangani L. Use of PRP, PRF and CGF in Periodontal Regeneration and Facial Rejuvenation-A Narrative Review. Biology (Basel). 2021 Apr 10;10(4):317. doi: 10.3390/biology10040317.
Cecerska-Heryc E, Goszka M, Serwin N, Roszak M, Grygorcewicz B, Heryc R, Dolegowska B. Applications of the regenerative capacity of platelets in modern medicine. Cytokine Growth Factor Rev. 2022 Apr;64:84-94. doi: 10.1016/j.cytogfr.2021.11.003. Epub 2021 Dec 2.
ElSherbeny K, Elshahat A, Gad A. Effect of Nano Fat Graft on the Healing of Donor Site of Split Thickness Skin Graft. The Egyptian Journal of Plastic and Reconstructive Surgery. 2023 Apr 1;47(2):79-88.
La Padula S, Ponzo M, Lombardi M, Iazzetta V, Errico C, Polverino G, Russo F, D'Andrea L, Hersant B, Meningaud JP, Salzano G, Pensato R. Nanofat in Plastic Reconstructive, Regenerative, and Aesthetic Surgery: A Review of Advancements in Face-Focused Applications. J Clin Med. 2023 Jun 28;12(13):4351. doi: 10.3390/jcm12134351.
Zou X, Dong Y, Alhaskawi A, Zhou H, Ezzi SHA, Kota VG, Abdulla MHAH, Abdalbary SA, Lu H, Wang C. Techniques and graft materials for repairing peripheral nerve defects. Front Neurol. 2024 Jan 22;14:1307883. doi: 10.3389/fneur.2023.1307883. eCollection 2023.
Gray KM, Burkat AJ, Arney LA, Peterman NJ, Mandala SR, Capito AE. Timing and Predictors of Upper Extremity Peripheral Nerve Reconstruction. JPRAS Open. 2025 Feb 27;44:308-315. doi: 10.1016/j.jpra.2025.02.018. eCollection 2025 Jun.
Grinsell D, Keating CP. Peripheral nerve reconstruction after injury: a review of clinical and experimental therapies. Biomed Res Int. 2014;2014:698256. doi: 10.1155/2014/698256. Epub 2014 Sep 3.
Bassilios Habre S, Bond G, Jing XL, Kostopoulos E, Wallace RD, Konofaos P. The Surgical Management of Nerve Gaps: Present and Future. Ann Plast Surg. 2018 Mar;80(3):252-261. doi: 10.1097/SAP.0000000000001252.
Sasaki R, Watanabe Y, Yamato M, Okamoto T. Tissue-engineered nerve guides with mesenchymal stem cells in the facial nerve regeneration. Neurochem Int. 2021 Sep;148:105062. doi: 10.1016/j.neuint.2021.105062. Epub 2021 May 15.
Vargo M, Ding P, Sacco M, Duggal R, Genther DJ, Ciolek PJ, Byrne PJ. The psychological and psychosocial effects of facial paralysis: A review. J Plast Reconstr Aesthet Surg. 2023 Aug;83:423-430. doi: 10.1016/j.bjps.2023.05.027. Epub 2023 May 19.
Hohman MH, Bhama PK, Hadlock TA. Epidemiology of iatrogenic facial nerve injury: a decade of experience. Laryngoscope. 2014 Jan;124(1):260-5. doi: 10.1002/lary.24117. Epub 2013 Apr 18.
Datta N, Fung E, Hatala A, Melnyk B, Bradley E. Imaging traumatic facial nerve injuries: a narrative review of current strategies and future directions for cranial nerve imaging. Plast Aesthet Res. 2023;10:51. http://dx.doi.org/10.20517/2347-9264.2023.22
Yoo MC, Chon J, Jung J, Kim SS, Bae S, Kim SH, Yeo SG. Potential Therapeutic Strategies and Substances for Facial Nerve Regeneration Based on Preclinical Studies. Int J Mol Sci. 2021 May 6;22(9):4926. doi: 10.3390/ijms22094926.
Other Identifiers
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PRF vs Nanofat in VII injury
Identifier Type: -
Identifier Source: org_study_id
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