Autologous Fat in Peripheral Nerve Injury

NCT04653129 | Unknown

• 1 other identifier: Fat for Nerve Injury
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nerve Injury

Keywords

fat graft; autologous fat; peripheral nerve injury

Outcome Measures

Primary Outcomes (2)

• 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

  6-12 months

• 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.

  6-12 months

Secondary Outcomes (2)

• Nerve conduction study

  6-12 months

• Disability of the Arm, Shoulder, and Hand (DASH) score

  6-12 months

Study Arms (2)

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

EXPERIMENTAL

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; Procedure: Primary Nerve Repair

Group (B): Standard primary nerve repair

ACTIVE COMPARATOR

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

Procedure: Primary Nerve Repair

Interventions

Autologous Fat Grafting PROCEDURE

* 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.

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

Primary Nerve Repair PROCEDURE

Standard Epineural nerve repairs will be performed with 9/0 nylon sutures, under magnification by an operating microscope.

Group (A): Primary nerve repair with autologous fat graft; Group (B): Standard primary nerve repair

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Acute median or ulnar nerve lacerations below elbow

You may not qualify if:

• Old Nerve lacerations \> 48 hours
• Nerve gap which requires nerve grafting
• Psychosocial issues that would limit participation and compliance

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• 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.

  PMID: 29710394 BACKGROUND

• 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.

  PMID: 20219599 BACKGROUND

• 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.

  PMID: 26273733 BACKGROUND

• 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.

  PMID: 26773850 BACKGROUND

• 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.

  PMID: 23653396 BACKGROUND

• 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.

  PMID: 19391342 BACKGROUND

• 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.

  PMID: 22411121 BACKGROUND

MeSH Terms

Conditions

Peripheral Nerve Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Tarek A El-Gammal, MD

  Assiut University Hospital - Orthopaedics & Traumatology Dept.

  STUDY DIRECTOR

• Youssef S Hassan, MD

  Assiut University Hospitals - Plastic Surgery Dept.

  STUDY CHAIR

• Awny M Asklany, MD

  Assiut University Hospitals - Plastic Surgery Dept.

  STUDY DIRECTOR

• Ahmed S Sharaf, MsC

  Assiut University Hospitals - Plastic Surgery Dept.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed S Sharaf, MsC

CONTACT

01090619155; ahmed.sharaf90@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the assessment of outcome measures will be performed by a dedicated surgeon not involved in the surgery or preoperative patient evaluation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: December 4, 2020
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2023
• Last Updated: December 7, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share