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

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

Trials, January 2016

26811067

Florian Neubrech, Sina Heider, Leila Harhaus, Berthold Bickert, Ulrich Kneser, Thomas Kremer

Complex 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. We 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. 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. ClinicalTrials.gov Identifier: NCT02372669 . Protocol Registration Receipt on 27 February 2015.