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Open Access 01-12-2016 | Study protocol

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

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

Published in: Trials | Issue 1/2016

Abstract

Background

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.

Methods/Design

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.

Discussion

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.

Trial registration

ClinicalTrials.gov Identifier: NCT02372669.

Protocol Registration Receipt on 27 February 2015.

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Title: Chitosan nerve tube for primary repair of traumatic sensory nerve lesions of the hand without a gap: study protocol for a randomized controlled trial
Authors: Florian Neubrech
Sina Heider
Leila Harhaus
Berthold Bickert
Ulrich Kneser
Thomas Kremer
Publication date: 01-12-2016
Publisher: BioMed Central
Published in: Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-015-1148-5

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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

Background

Methods/Design

Discussion

Trial registration

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Springer Medicine

Abstract

Background

Methods/Design

Discussion

Trial registration

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