Neurorrhaphy Only vs Neurorrhaphy Plus PRF vs Neurorrhaphy Plus Nano-fat in Management of Traumatic Facial Nerve Injury

NCT06977607 | Active Not Recruiting DMC

• 1 other identifier: PRF vs Nanofat in VII injury
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The current clinical trial aims to identify the most significant intervention that improves the outcome of post-traumatic facial nerve injury by comparing the following different modalities: neurorrhaphy alone, neurorrhaphy with PRF injection, and neurorrhaphy with Nanofat stem cells graft injection for significantly better Facial nerve regeneration.

Conditions

Facial Nerve Injuries; Facial Trauma

Keywords

PRF; nanofat; facial nerve

Outcome Measures

Primary Outcomes (1)

• Physical examination of the affected facial muscles after injury and Record the time taken for the first muscle excursion to occur following each facial nerve repair modality

  \*\*Record the First Occurrence of Muscle Excursion and Movement by facial nerve Physical examination\*\* Based on monthly follow-up records Physical examination of the facial muscles affected after the nerve repair is done. Record the time taken for the first muscle excursion ( movement) to occur following each facial nerve repair modality. Comparing the time interval for each modality - the earlier the occurrence, the better the outcome.

  12 months

Study Arms (3)

Platelets Rich Fibrin

EXPERIMENTAL

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.

Procedure: Platelets Rich Fibrin

Repair only

EXPERIMENTAL

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.

Procedure: Repair only

Nano-fat stem cells (NFSCs)

EXPERIMENTAL

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.

Procedure: Nano-fat stem cells (NFSCs)

Interventions

Platelets Rich Fibrin PROCEDURE

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)

Also known as: PRF

Platelets Rich Fibrin

Nano-fat stem cells (NFSCs) PROCEDURE

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).

Also known as: NFSCs

Nano-fat stem cells (NFSCs)

Repair only PROCEDURE

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).

Also known as: facial nerve neurorrhaphy

Repair only

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Recent Facial nerve injury within the first 24 hours of trauma.
• Grade V according to Sunderland classification.

You may not qualify if:

• Diabetes Mellitus.
• Steroid Dependent.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Asyut Governorate, 71515, Egypt

Location

Related Publications (13)

• 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.

  PMID: 33920204 BACKGROUND

• 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.

  PMID: 34924312 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 37445386 BACKGROUND

• 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.

  PMID: 38318237 BACKGROUND

• 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.

  PMID: 40271482 BACKGROUND

• 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.

  PMID: 25276813 BACKGROUND

• 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.

  PMID: 29166306 BACKGROUND

• 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.

  PMID: 34004239 BACKGROUND

• 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.

  PMID: 37311285 BACKGROUND

• 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.

  PMID: 23606475 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 34066483 BACKGROUND

MeSH Terms

Conditions

Facial Nerve Injuries

Condition Hierarchy (Ancestors)

Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Injuries; Cranial Nerve Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Doaa M. Selim, Specialist

  University of Assiut

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Sample Size and Group Allocation: A total of 21 patients will be randomly assigned to one of three groups: A, B, or C, with 7 patients in each group.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist

Model Details: * Twenty-one Patients will be randomly assigned to Groups A, B, or C ( 3 equal groups). * 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.

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: May 18, 2025
• Study Start: October 1, 2024
• Primary Completion: December 30, 2025
• Study Completion: January 1, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: two years
• Access Criteria: open access

Locations

EG (1)