NCT02359825.

Study name	Nerve repair using hydrophilic polymers to promote immediate fusion of severed axons and swift return of function
Methods	Randomised, single‐blind, parallel‐group
Participants	Planned recruitment: 18 People with diagnosis of Sunderland Class 5 traumatic neuropathy (transection injury) of a digital nerve in the upper extremity who are candidates for immediate surgical repair, within 72 hours of injury or 48 hours if the injury requires nerve grafting. Participants are required to have no significant comorbidities to prevent immediate repair and be willing to comply with treatment and evaluation schedule. People with peripheral nerve injuries complicated by significant vascular or orthopaedic damage were eligible. Exclusion criteria: gross contamination of injuries, inadequate soft tissue coverage, or planned staged repair; diabetes, diagnosed neuromuscular disease, undergoing chemotherapy, radiotherapy, or other treatments known to affect the growth of the neural and vascular system; people enrolled in another investigational study, those unlikely to complete the normal regimen of occupational therapy; time of injury outside study parameters
Interventions	3 'no intervention' groups (no medication used) Standard epineural repair < 24 hours after injury Epineural repair following irrigation with standard epineural repair alone > 24 to < 72 hours after injury Epineural repair with auto grafting within 48 hours of injury 3 experimental groups (with PEG‐assisted axonal fusion technique) Epineural repair < 24 hours after injury using PEG epineural repair Epineural repair > 24 but < 72 hours after injury using PEG epineural repair Epineural repair with autografting within 48 hours of injury, using PEG epineural repair with auto grafting Quote: "For the control groups, epineural repair or interposition grafting will be undertaken in the standard end‐to‐end fashion using interrupted nylon suture after irrigation of the wound with normal saline as deemed necessary by the operating surgeon. For the experimental group, the nerve(s) will be repaired using standard suture neurorrhaphy techniques and a 149.25 mM (50%) solution of PEG 3.35 kD in sterile water will then be irrigated onto the neurorrhaphy site for one minute. Following this, the approximated nerve ends will be irrigated with sterile water gently for 2 minutes. All wounds will be closed in the fashion deemed appropriate by the operating surgeon."
Outcomes	Return of nerve function as measured by (Medical Research Council Classification) (time frame: 12 months)
Starting date	1 September 2015
Contact information	Wesley Thayer, Julia Yao, Vanderbilt University Medical Centre
Notes