Enhancing the Outcome of Traumatic Sensory Nerve Lesions of the Hand by Additional Use of a Chitosan Nerve Tube in Primary Nerve Repair: A Randomized Controlled Bicentric Trial

Abstract

BACKGROUND: Peripheral sensory nerve injuries present a significant yet common challenge in acute hand trauma surgery. Standard treatment remains microsurgical end-to-end nerve repair where appropriate. Permanent loss of sensitivity and painful neuroma formation are typical sequelae of unsuccessful surgery. The objective of this study was to evaluate whether the additional use of a chitosan nerve tube in primary nerve repair positively influences sensory recovery. METHODS: A randomized, controlled, two-center trial with parallel group design and double-blind assessment was conducted to demonstrate the superiority of the additional use of a chitosan nerve tube compared with microsurgical nerve repair alone. Seventy-four participants were enrolled. The primary outcome parameter used was degree of static two-point discrimination at 6 months after surgery. Additional secondary outcome parameters included filament recognition testing (Semmes-Weinstein); pain; neuroma development; and the Disabilities of the Arm, Shoulder and Hand score. RESULTS: Nerve repair with additional use of chitosan nerve tubes (intervention group) significantly increased both tactile gnosis (expressed by two-point discrimination) and sensitivity (expressed by Semmes-Weinstein testing). The mean two-point discrimination at 6-month follow-up was 8 mm (range, 2 to 20 mm) in the control group and 6.3 mm (range, 1 to 15 mm) in the intervention group, respectively (p = 0.029). Two-point discrimination correlated with the Disabilities of the Arm, Shoulder and Hand score. In the control and intervention groups, respectively, three versus zero neuromas were found. CONCLUSIONS: Peripheral sensory nerve regeneration can be improved significantly by additional use of a chitosan nerve tube. An improved ability of static two-point discrimination is clinically relevant. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.