Autologous Fat in Peripheral Nerve Injury

Assiut University

Status: Unknown

Conditions: Nerve Injury

Treatments: Procedure: Autologous Fat Grafting; Procedure: Primary Nerve Repair

Study type: Interventional

Funder types: Other

Identifiers

NCT04653129

Fat for Nerve Injury

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

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

Experimental group

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

Treatment:

Procedure: Primary Nerve Repair

Procedure: Autologous Fat Grafting

Group (B): Standard primary nerve repair

Active Comparator group

Description:

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

Treatment:

Procedure: Primary Nerve Repair