Clinical trial NCT06977607: Neurorrhaphy Only vs Neurorrhaphy Plus PRF vs Neurorrhaphy Plus Nano-fat in Management of Traumatic Facial Nerve Injury
Official title: Comparative Study Between Platelet- Rich Fibrin Versus Nano-Fat in Improving Facial Nerve Regeneration After Traumatic Injury
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Facial Nerve Injuries
Facial Trauma
Keywords: PRF
nanofat
facial nerve
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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* Twenty-one closed envelopes will be used; each 7 carries one of the three groups that will be randomly withdrawn at the time of surgery.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Diabetes Mellitus.
* Steroid Dependent.

Primary outcomes:
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
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: University of Assiut
name: Doaa M. Selim, Specialist
role: PRINCIPAL_INVESTIGATOR
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