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.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2017
INTERVENTION: 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 (Neurowrap). 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 CONDITION: Digital nerve laceration PRIMARY OUTCOME: Touch/pressure threshold SECONDARY OUTCOME: Cold intolerance measured using a likert scale. The participant will be provided with a definition of cold intolerance, and asked to indicate their current cold intolerance intensity and this will be converted to an ordinal score (none/minor = 3, moderate = 2, disturbing = 1, and hinders function = 0). Hyperaesthesia measured using a likert scale. The participant will be provided with a definition of hyperaesthesia, and asked to indicate their current hyperaesthesia intensity and this will be converted to an ordinal score (none/minor = 3, moderate = 2, disturbing = 1, and hinders function = 0). Moving two point discrimination Overall recovery will be measured using the global estimation of recovery (GER), a 100 mm visual analogue scale, with 0 mm representing not at all recovered and 100 mm representing fully recovered (Rosen, 1996). Participants will be asked to quantify their degree of recovery by placing a vertical mark on the line. Pain at rest was measured using a 100 mm visual analogue scale, with 0 mm representing no pain and 100 mm representing worst pain imaginable. Participation in work or usual roles will be measured via direct questioning. Participants will be questioned as to whether they have returned to their work or usual role/s and, if so, whether they are undertaking their full duties or modified duties. Static two point discrimination Total active range of motion for the injured digit will be calculated as the difference between composite flexion and composite loss of extension (ASSH, 1990) with any hyperextension (beyond 0 deg) denoted as 0 deg for the purpose of the calculation. Measurements will be taken using dorsal placement of a hand‐held finger goniometer (Rolyan, Patterson Medical Holdings Inc, Bolingbrook, Illinois USA) and reported in deg, with the shoulder, elbow and wrist positioning standardised.. 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
Epistemonikos ID: ba406237b454d88fdf2de5e5f92c19f71bf6dcba
First added on: Aug 23, 2024