Facial Nerve InjuriesfacialinjuryNCT06977607
Neurorrhaphy Only vs Neurorrhaphy Plus PRF vs Neurorrhaphy Plus Nano-fat in Management of Traumatic Facial Nerve Injury
A study testing Platelets Rich Fibrin, Nano-fat stem cells (NFSCs) and Repair only in people with Facial Nerve Injuries and Facial Trauma, run by Assiut University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Facial Nerve Injuries, Facial Trauma
- What is being tested?
- Platelets Rich Fibrin, Nano-fat stem cells (NFSCs) and Repair only
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Recent Facial nerve injury within the first 24 hours of trauma.
- Grade V according to Sunderland classification.
Who cannot join
- Diabetes Mellitus.
- Steroid Dependent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Platelet- Rich Fibrin Versus Nano-Fat in Improving Facial Nerve Regeneration After Traumatic Injury
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.
Read the detailed description
Despite advances in microsurgical technology and an improved understanding of nerve regeneration, obtaining satisfactory results after facial nerve injury remains a challenging clinical problem.
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
- Facial Nerve Injuries, Facial Trauma
- Being tested
- Platelets Rich Fibrin, Nano-fat stem cells (NFSCs), Repair only
- Keywords
- PRF, nanofat, facial nerve
- Medical subject headings
- Facial Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelets Rich FibrinProcedure or surgery
Also called PRF
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)Procedure or surgery
Also called 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 onlyProcedure or surgery
Also called facial nerve neurorrhaphy
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Nano-fat stem cells (NFSCs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start1 Oct 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Facial Nerve InjuriesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- * 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.
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Mohie Selim, Assiut University
- Investigators
- Doaa M. Selim, Specialist, Principal investigator, University of Assiut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977607
- Sponsor's protocol ID
- PRF vs Nanofat in VII injury
- Acronym
- facialinjury
- Status last verified
- May 2025
- First submitted
- 16 Jan 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: International publishing after finishing the study and the results
Publications
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.
PubMed 33920204Cecerska-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.
PubMed 34924312ElSherbeny 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.
PubMed 37445386Zou 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.
PubMed 38318237Gray 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.
PubMed 40271482Grinsell 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.
PubMed 25276813Bassilios 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.
PubMed 29166306Sasaki 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.
PubMed 34004239Vargo 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.
PubMed 37311285Hohman 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.
PubMed 23606475Datta 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.
PubMed 34066483
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Platelet- Rich Fibrin Versus Nano-Fat in Improving Facial Nerve Regeneration After Traumatic Injury
- ClinicalTrials.gov ID
- NCT06977607
- Acronym / sponsor ID
- facialinjury / PRF vs Nanofat in VII injury
- Conditions
- Facial Nerve Injuries, Facial Trauma
- Keywords
- PRF, nanofat, facial nerve
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Despite advances in microsurgical technology and an improved understanding of nerve regeneration, obtaining satisfactory results after facial nerve injury remains a challenging clinical problem.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- * 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.
| Arm | Type | Receives |
|---|---|---|
| Platelets Rich Fibrin | Experimental | Procedure: Platelets Rich FibrinInjection 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. |
| Repair only | Experimental | Procedure: Repair onlyNeurorrhaphy 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. |
| Nano-fat stem cells (NFSCs) | Experimental | Procedure: 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Recent Facial nerve injury within the first 24 hours of trauma.
- Grade V according to Sunderland classification.
Key exclusion criteria (2 listed)
- Diabetes Mellitus.
- Steroid Dependent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelets Rich FibrinAlso: PRFRepair 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) | Procedure or surgery | Platelets Rich Fibrin |
| Nano-fat stem cells (NFSCs)Also: NFSCsRepair 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). | Procedure or surgery | Nano-fat stem cells (NFSCs) |
| Repair onlyAlso: facial nerve neurorrhaphyfacial 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). | Procedure or surgery | Repair only |
Primary outcome
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
Time frame: 12 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Results publication: PubMed 33920204Mijiritsky 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.
- Results publication: PubMed 34924312Cecerska-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.
- Results publicationElSherbeny 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.
- Results publication: PubMed 37445386La 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.
- Results publication: PubMed 38318237Zou 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.
- Results publication: PubMed 40271482Gray 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.
- Results publication: PubMed 25276813Grinsell 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.
- Results publication: PubMed 29166306Bassilios 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.
- Results publication: PubMed 34004239Sasaki 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.
- Results publication: PubMed 37311285Vargo 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.
- Results publication: PubMed 23606475Hohman 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.
- Results publicationDatta 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
- Individual participant dataSharing planned: Yes. International publishing after finishing the study and the results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doaa M. Selim, Specialist principal investigator
University of Assiut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelets Rich Fibrin, Nano-fat stem cells (NFSCs) and Repair only in people with Facial Nerve Injuries and Facial Trauma, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06977607, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.