A randomised trial comparing two new types of nerve repair (Neurawrap and Neuragen) to the conventional type of nerve repair among patients with finger nerve injury.

Conditions

None listed

Brief summary

Peripheral nerve repair still remains a challenging problem for surgeons. Despite improvements in microsurgical techniques, the sensory recovery remains suboptimal. With the advancement in molecular biology and tissue engineering techniques there has been further development in the realm of nerve repair using various synthetic and biological materials to develop nerve wraps and conduits. It is now vital to be able to compare these newer repair techniques with conventional methods to determine whether they provide an improvement in outcome in the form of sensory recovery. The aim of this study is to compare outcomes between 3 types of digital nerve repair techniques following digital nerve laceration where primary neurorrhaphy is possible. These 3 arms are direct end to end repair of severed nerve ends, direct end to end repair with protection of site using a collagen nerve wrap and short gap neurorrhaphy using a collagen conduit.

Related papers

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Interventions

All patients will undergo a surgical procedure by a hand surgeon in an operating theatre to repair a lacerated nerve. Arm 1. Direct digital neurorrhaphy within a collagen nerve wrap (Neurawrap). In this procedure the nerve laceration will be identified during surgery and then repaired using microsurgical suturing. In addition the nerve wrap will be placed around the repair site to protect the repair site during healing. Arm 2. Short gap neurorrhaphy using a collagen conduit (Neuragen). In this

All patients will undergo a surgical procedure by a hand surgeon in an operating theatre to repair a lacerated nerve. Arm 1. Direct digital neurorrhaphy within a collagen nerve wrap (Neurawrap). In this procedure the nerve laceration will be identified during surgery and then repaired using microsurgical suturing. In addition the nerve wrap will be placed around the repair site to protect the repair site during healing. Arm 2. Short gap neurorrhaphy using a collagen conduit (Neuragen). In this procedure the nerve laceration will be identified during surgery and then the 2 ends of the severed nerve are secured inside the nerve conduit intentionally leaving a 2mm gap between the nerve ends within the conduit. This is performed using similar microsurgical techniques as Arm 1. Both procedures would take approximately 60 minutes to perform.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

No

Inclusion criteria

Age between 18 to 65yo Male or Female Treated within 14 days of injury. Laceration to digital nerve where gap closure can be achieved by flexion of the extremity and the nerve can be held together by a single 9-0 nylon suture Lacerations from proximal end of A1 pulley to trifurcation of nerve distally amenable to primary repair under minimal tension Patients with associated injuries such as tendon and/or artery injury Signed informed consent

Exclusion criteria

Patients with nerve injuries at more than one level Communication problems due to language or severe psychiatric issues Nerve gaps requiring bridging with grafts or where the nerve cannot be held together by a single 9-0 nylon suture Known allergy to bovine derived products Disorders known to affect the peripheral nervous system (PNS) such as diabetes mellitus, chronic heavy alcohol use or toxic nerve lesions Associated fracture or amputation Receiving immunosuppressive or antineoplastic agents within 7 days of the study Actively infected wound Uncooperative or unsuitable for completion of the study

Outcome results