Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
44 participants
INTERVENTIONAL
2021-01-31
2023-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
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.
Primary Nerve Repair
Standard Epineural nerve repairs will be performed with 9/0 nylon sutures, under magnification by an operating microscope.
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.
Primary Nerve Repair
Standard Epineural nerve repairs will be performed with 9/0 nylon sutures, under magnification by an operating microscope.
Interventions
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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.
Primary Nerve Repair
Standard Epineural nerve repairs will be performed with 9/0 nylon sutures, under magnification by an operating microscope.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Nerve gap which requires nerve grafting
* Psychosocial issues that would limit participation and compliance
16 Years
65 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Ahmed ElSayed Sharaf Ahmed
Assistant Lecturer
Principal Investigators
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Tarek A El-Gammal, MD
Role: STUDY_DIRECTOR
Assiut University Hospital - Orthopaedics & Traumatology Dept.
Youssef S Hassan, MD
Role: STUDY_CHAIR
Assiut University Hospitals - Plastic Surgery Dept.
Awny M Asklany, MD
Role: STUDY_DIRECTOR
Assiut University Hospitals - Plastic Surgery Dept.
Ahmed S Sharaf, MsC
Role: PRINCIPAL_INVESTIGATOR
Assiut University Hospitals - Plastic Surgery Dept.
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Fat for Nerve Injury
Identifier Type: -
Identifier Source: org_study_id