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.
Highlights
Complex peripheral nerve injuries of the hand include at least 300,000 cases per year in Europe
In 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
Design of the study and setting To answer the question of whether the additional use of a chitosan nerve tube in primary microsurgical repair of traumatic sensory nerve lesions of the hand without a gap will improve the recovery of sensitivity, a randomized controlled multicenter trial with parallel group design was planned to show superiority for the additional use of a nerve tube
Summary
Standard therapy for traumatic sensory nerve lesions of the hand includes a direct tension-free microsurgical repair for lesions without a gap and autologous nerve grafting from another body region for lesions with a gap [6]. The proposed study will compare standard treatment and the use of nerve tubes in a prospective controlled trial setting. Some hand surgery departments use nerve tubes in addition to a direct nerve suture for lesions without a gap in hopes of improving the results, but such an effect has not yet been proven. The major study objective of this trial will be to answer the question of whether the additional use of a chitosan nerve tube in primary microsurgical repair of traumatic sensory nerve lesions of the hand without a gap will improve the recovery of sensitivity. If we obtain promising results, we will expand the use of the chitosan nerve tube to use in further studies for traumatic sensory nerve lesions of the hand with a gap as an alternative to autologous nerve grafting and for traumatic nerve lesions of the forearm that include motor axons and have an even more significant burden of disease. All study centers are certified Hand Trauma Centers by the Federation for European Societies for Surgery of the Hand (FESSH)
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