Clinical safety of collagen nerve scaffold with longitudinally oriented microchannels in bridging peripheral nerve defect

Abstract

Objective To evaluate the clinical safety of the collagen nerve scaffold with longitudinally oriented microchannels in bridging peripheral nerve defect. Methods Five patients with 8 peripheral nerve defects of 18 to 30 (mean, 23.8) mm in length were involved in the pilot study and treated from July, 2017 to March, 2018, including 6 digital nerves and 2 medial antebrachial cutaneous nerves. The defects were repaired with the collagen nerve scaffold with longitudinally oriented microchannels independently developed. Routine therapy of prophylactic systemic antibiotics but no immunosuppressive drugs was given to all patients post-operatively. All patients were followed-up by regular review in the outpatient department combined with WeChat and telephone. The clinical safety of the nerve scaffold was preliminarily evaluated through observing the condition of the healing of the local wound and the whole body. The blood routine examineation and biochemical test were detected. The statistical analysis of the measurement data was performed by the analysis of variance of repeated measurement data, and the difference was statistically significant when P<0.05. Results All patients were followed-up for 7 to 15 months (average, 10 months). No adverse events such as infection, allergy, damage of liver and kidney function occurred. The operative incisions healed primarily, with no redness, exudation and rupture in the local area. There was no systemic symptoms such as fever, nausea, vomiting, skin itching, etc. The results of blood routine tests and biochemical tests were normal. The data of tests was compared, and the difference was not statistically significant (P>0.05). Conclusion The preliminary study shows that it is clinically safe to bridge peripheral nerve defects with the collagen nerve scaffold with longitudinally oriented microchannels. Key words: Collagen nerve scaffold with longitudinally oriented microchannels; Peripheral nerve; Nerve defect; Safety