Chitosan nerve tube for primary repair of traumatic sensory nerve lesions of the hand without a gap: study protocol for a randomized controlled trial

Abstract

BackgroundComplex peripheral nerve injuries of the hand include at least 300,000 cases per year in Europe. The standard treatment involves a microsurgical end-to-end suture of traumatic sensory nerve lesions of the hand without a gap. The objective of this study protocol is to evaluate whether the additional use of a chitosan nerve tube in primary repair of traumatic sensory nerve lesions of the hand without a gap has an effect on the recovery of sensitivity.Methods/DesignWe planned a randomized double-blind controlled multicenter trial with a parallel group design in order to show superiority for the additional use of a chitosan nerve tube. This study will enroll 100 participants with traumatic sensory nerve lesions of the hand without a gap from three Trauma Care Centers. Participants will be randomized in a 1:1 ratio to primary microsurgical repair of the injured nerve with the additional use of a chitosan nerve tube or direct tension free microsurgical repair of the injured nerve alone. The static two-point discrimination of the injured finger after 6 months will be the primary outcome parameter.DiscussionIn the proposed study, the additional use of a chitosan nerve tube for a primary microsurgical repair of traumatic sensory nerve lesions of the hand without a gap will be evaluated in a prospective randomized double-blind controlled multicenter trial for the first time to create the highest possible evidence for the procedure.Trial registrationClinicalTrials.gov Identifier: NCT02372669.Protocol Registration Receipt on 27 February 2015.

Biomaterials and Cellular Systems at the Forefront of Peripheral Nerve Regeneration

“…The Reaxon ® is flexible and resistant to collapse, and transparent, which facilitates the insertion of the nerve ends and the application of the anchoring sutures. The electrostatic interaction of the surface of Reaxon ® Nerve Guide (positively charged) and the molecules or cells used in nerve repair (negatively charged) promotes the regenerative phenomena [149]. Fornasari et al conducted a trial study on the mouse model using Reaxon ® Nerve Guides, comparing the use of the commercial tube alone with a combination with muscular tissue (for the production of neuregulin 1, a stimulant of activity and survival of Schwann cells) and autografts.…”

The role of chitin and chitosan in peripheral nerve reconstruction

“…The duration of the project is estimated at 36 months, until the completion of all follow-up examinations. 22 …”

Versorgungsstrategie von Nervenverletzungen bei schwerem Weichteilschaden

“…Von einer langstreckigen interfaszi- kulären Neurolyse ist abzusehen, um sich austauschende Faszikel nicht zu verletzen [17]. Um Vernarbungen des Nerven selbst nach dem "iatrogenen Trauma" der Neurolyse als auch durch den begleitenden Weichteilschaden zu minimieren, ist im Anschluss eine Ummantelung des Nerven mit Fibrinkleber [18] oder Nervetubes [19] Kommerzielle Nervenconduits werden inzwischen von zahlreichen Herstellern angeboten. Im Wesentlichen unterscheiden sich in ihren Zusammensetzungen und können aus Kollagen, aus Milchsäureverbindungen, aus Polyglykolgewebe oder Chitosanen bestehen.…”