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Autologous Fat in Peripheral Nerve Injury

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ClinicalTrials.gov Identifier: NCT04653129
Recruitment Status : Not yet recruiting
First Posted : December 4, 2020
Last Update Posted : December 7, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmed ElSayed Sharaf Ahmed, Assiut University

Study Description
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Brief Summary:
The aim of this study is to assess the efficacy of autologous fat graft in enhancing peripheral nerve regeneration. The investigators hypothesize that fat grafting will allow for faster and greater recovery of motor and sensory function following surgical repair of injured peripheral nerves.

Condition or disease Intervention/treatment Phase
Nerve Injury Procedure: Autologous Fat Grafting Procedure: Primary Nerve Repair Not Applicable

Detailed Description:

Traumatic injuries to peripheral nerves are a frequent finding after hand trauma. High morbidity after nerve injuries mainly affects the younger and working population, with consequent decrease in life quality and productivity .

Even in direct nerve repair and microsurgical nerve coaptation, regeneration is often suboptimal with incomplete target reinnervation. Suboptimal outcome is attributed to axonal degeneration, fibrotic scar formation, and neuromas at the site of injury.

The use of adipose tissue has become very popular in tissue engineering and reconstructive surgery in recent years. It is proposed as a "regenerative tool" for various tissues, including peripheral nerves, because it offers an effective and minimally invasive procedure for obtaining stem cells.

Unprocessed fat grafting can provide a simple approach to improve peripheral nerve regeneration by means of neoangiogenesis & inflammatory response modulation. Furthermore, it serves as a good protective barrier in peripheral nerve surgery, reducing fibrosis and adhesions.

A recent study advocated by Tuncel et al, concluded that combined use of autologous fat graft with surgical repair methods induced significantly better regeneration in rats [3]. In another study by Kilic et al, using adipose tissue flap in a crush injury model in rats was found to be superior to other groups in myelin thickness, nerve fiber density, axon count, and functional recovery at 4 weeks. They concluded that fat tissue seems to promote nerve regeneration because of its stem cell content.

To our knowledge, no prior studies have examined the use of fat graft in peripheral nerve repair in humans. So, the investigators proposed this clinical study to evaluate the outcomes of primary nerve repair combined with autologous fat graft in peripheral nerve injuries.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: the assessment of outcome measures will be performed by a dedicated surgeon not involved in the surgery or preoperative patient evaluation
Primary Purpose: Treatment
Official Title: Use of Autologous Fat to Improve Functional Outcomes After Upper Limb Nerve Injuries
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Group (A): Primary nerve repair with autologous fat graft
Standard nerve repair will be performed with 9/0 nylon sutures, under magnification by an operating microscope with autologous fat grafting around site of repair
 Procedure: Autologous Fat Grafting
  • The fat grafts will be harvested from the abdomen or lateral thighs in a closed sterile system, then prepared according to Coleman guidelines. The blood and oil layers are then separated from the adipose tissue.
  • The lipoaspirate will be injected based on a technique described by Vaienti et al, by 17-gaug cannula which will be inserted through the skin around the main incision at the nerve repair site, and the fat graft will be injected after closure of the skin.

Procedure: Primary Nerve Repair
Standard Epineural nerve repairs will be performed with 9/0 nylon sutures, under magnification by an operating microscope.
Active Comparator: Group (B): Standard primary nerve repair
Standard nerve repair will be performed with 9/0 nylon sutures, under magnification by an operating microscope without fat grafting.
 Procedure: Primary Nerve Repair
Standard Epineural nerve repairs will be performed with 9/0 nylon sutures, under magnification by an operating microscope.


Outcome Measures
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Primary Outcome Measures :
  1. Modified British Medical Research Council, sensory grading [ Time Frame: 6-12 months ]
    standardized clinical assessment of sensory function using two-point discrimination and monofilament testing by a score from S0 to S4; the higher score indicates better sensation

  2. Modified British Medical Research Council, motor grading [ Time Frame: 6-12 months ]
    standardized clinical assessment of motor function on a scale from M0 to M5; the higher score indicates better strength.


Secondary Outcome Measures :
  1. Nerve conduction study [ Time Frame: 6-12 months ]
    measure for amplitude of response, latency of response and velocity of response measurements.

  2. Disability of the Arm, Shoulder, and Hand (DASH) score [ Time Frame: 6-12 months ]
    self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100 (most severe disability)


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Acute median or ulnar nerve lacerations below elbow

Exclusion Criteria:

  • Old Nerve lacerations > 48 hours
  • Nerve gap which requires nerve grafting
  • Psychosocial issues that would limit participation and compliance
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04653129


Contacts
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Contact: Ahmed S Sharaf, MsC 01090619155 ext +2 ahmed.sharaf90@aun.edu.eg

Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Tarek A El-Gammal, MD Assiut University Hospital - Orthopaedics & Traumatology Dept.
Study Chair: Youssef S Hassan, MD Assiut University Hospitals - Plastic Surgery Dept.
Study Director: Awny M Asklany, MD Assiut University Hospitals - Plastic Surgery Dept.
Principal Investigator: Ahmed S Sharaf, MsC Assiut University Hospitals - Plastic Surgery Dept.
More Information
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Publications:

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Responsible Party: Ahmed ElSayed Sharaf Ahmed, Assistant Lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT04653129    
Other Study ID Numbers: Fat for Nerve Injury
First Posted: December 4, 2020    Key Record Dates
Last Update Posted: December 7, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmed ElSayed Sharaf Ahmed, Assiut University:
fat graft
autologous fat
peripheral nerve injury
Additional relevant MeSH terms:
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Peripheral Nerve Injuries
Wounds and Injuries
Peripheral Nervous System Diseases
 Neuromuscular Diseases
Nervous System Diseases
Trauma, Nervous System