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Autologous Fat in Peripheral Nerve Injury

Primary Purpose

Nerve Injury

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Autologous Fat Grafting
Primary Nerve Repair
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nerve Injury focused on measuring fat graft, autologous fat, peripheral nerve injury

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Group (A): Primary nerve repair with autologous fat graft

    Group (B): Standard primary nerve repair

    Arm Description

    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

    Standard nerve repair will be performed with 9/0 nylon sutures, under magnification by an operating microscope without fat grafting.

    Outcomes

    Primary Outcome Measures

    Modified British Medical Research Council, sensory grading
    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
    Modified British Medical Research Council, motor grading
    standardized clinical assessment of motor function on a scale from M0 to M5; the higher score indicates better strength.

    Secondary Outcome Measures

    Nerve conduction study
    measure for amplitude of response, latency of response and velocity of response measurements.
    Disability of the Arm, Shoulder, and Hand (DASH) score
    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)

    Full Information

    First Posted
    November 27, 2020
    Last Updated
    December 3, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04653129
    Brief Title
    Autologous Fat in Peripheral Nerve Injury
    Official Title
    Use of Autologous Fat to Improve Functional Outcomes After Upper Limb Nerve Injuries
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2021 (Anticipated)
    Primary Completion Date
    January 2022 (Anticipated)
    Study Completion Date
    January 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nerve Injury
    Keywords
    fat graft, autologous fat, peripheral nerve injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    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
    Allocation
    Randomized
    Enrollment
    44 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group (A): Primary nerve repair with autologous fat graft
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Group (B): Standard primary nerve repair
    Arm Type
    Active Comparator
    Arm Description
    Standard nerve repair will be performed with 9/0 nylon sutures, under magnification by an operating microscope without fat grafting.
    Intervention Type
    Procedure
    Intervention Name(s)
    Autologous Fat Grafting
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Primary Nerve Repair
    Intervention Description
    Standard Epineural nerve repairs will be performed with 9/0 nylon sutures, under magnification by an operating microscope.
    Primary Outcome Measure Information:
    Title
    Modified British Medical Research Council, sensory grading
    Description
    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
    Time Frame
    6-12 months
    Title
    Modified British Medical Research Council, motor grading
    Description
    standardized clinical assessment of motor function on a scale from M0 to M5; the higher score indicates better strength.
    Time Frame
    6-12 months
    Secondary Outcome Measure Information:
    Title
    Nerve conduction study
    Description
    measure for amplitude of response, latency of response and velocity of response measurements.
    Time Frame
    6-12 months
    Title
    Disability of the Arm, Shoulder, and Hand (DASH) score
    Description
    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)
    Time Frame
    6-12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed S Sharaf, MsC
    Phone
    01090619155
    Ext
    +2
    Email
    ahmed.sharaf90@aun.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tarek A El-Gammal, MD
    Organizational Affiliation
    Assiut University Hospital - Orthopaedics & Traumatology Dept.
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Youssef S Hassan, MD
    Organizational Affiliation
    Assiut University Hospitals - Plastic Surgery Dept.
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Awny M Asklany, MD
    Organizational Affiliation
    Assiut University Hospitals - Plastic Surgery Dept.
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Ahmed S Sharaf, MsC
    Organizational Affiliation
    Assiut University Hospitals - Plastic Surgery Dept.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29710394
    Citation
    Di Summa PG, Schiraldi L, Cherubino M, Oranges CM, Kalbermatten DF, Raffoul W, Madduri S. Adipose Derived Stem Cells Reduce Fibrosis and Promote Nerve Regeneration in Rats. Anat Rec (Hoboken). 2018 Oct;301(10):1714-1721. doi: 10.1002/ar.23841. Epub 2018 Jul 10.
    Results Reference
    background
    PubMed Identifier
    20219599
    Citation
    Ngeow WC. Scar less: a review of methods of scar reduction at sites of peripheral nerve repair. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Mar;109(3):357-66. doi: 10.1016/j.tripleo.2009.06.030. Erratum In: Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Aug;110(2):271.
    Results Reference
    background
    PubMed Identifier
    26273733
    Citation
    Tuncel U, Kostakoglu N, Turan A, Cevik B, Cayli S, Demir O, Elmas C. The Effect of Autologous Fat Graft with Different Surgical Repair Methods on Nerve Regeneration in a Rat Sciatic Nerve Defect Model. Plast Reconstr Surg. 2015 Dec;136(6):1181-1191. doi: 10.1097/PRS.0000000000001822.
    Results Reference
    background
    PubMed Identifier
    26773850
    Citation
    Walocko FM, Khouri RK Jr, Urbanchek MG, Levi B, Cederna PS. The potential roles for adipose tissue in peripheral nerve regeneration. Microsurgery. 2016 Jan;36(1):81-8. doi: 10.1002/micr.22480. Epub 2015 Sep 7.
    Results Reference
    background
    PubMed Identifier
    23653396
    Citation
    Kilic A, Ojo B, Rajfer RA, Konopka G, Hagg D, Jang E, Akelina Y, Mao JJ, Rosenwasser MP, Tang P. Effect of white adipose tissue flap and insulin-like growth factor-1 on nerve regeneration in rats. Microsurgery. 2013 Jul;33(5):367-75. doi: 10.1002/micr.22101. Epub 2013 May 7.
    Results Reference
    background
    PubMed Identifier
    19391342
    Citation
    Iannace C, Di Libero L, Manetta F, Sciascia V, Pizza A, Napolitano S, Ferraro A, Scetta G, Esposito D, Varriale S, Candela G, Caracciolo F. [Coleman lipofilling: experience of an Italian group and review of the literature]. Chir Ital. 2009 Jan-Feb;61(1):67-75. Italian.
    Results Reference
    background
    PubMed Identifier
    22411121
    Citation
    Vaienti L, Gazzola R, Villani F, Parodi PC. Perineural fat grafting in the treatment of painful neuromas. Tech Hand Up Extrem Surg. 2012 Mar;16(1):52-5. doi: 10.1097/BTH.0b013e31823cd218.
    Results Reference
    background

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    Autologous Fat in Peripheral Nerve Injury

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