文章基本信息

标题：Chitosan nerve tube for primary repair of traumatic sensory nerve lesions of the hand without a gap: study protocol for a randomized controlled trial
本地全文：下载
作者：Florian Neubrech ; Sina Heider ; Leila Harhaus 等
期刊名称：Trials
印刷版ISSN：1745-6215
电子版ISSN：1745-6215
出版年度：2016
卷号：17
期号：1
页码：1
DOI：10.1186/s13063-015-1148-5
语种：English
出版社：BioMed Central
摘要：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.
关键词：Nerve lesions of the hand ; peripheral nerve surgery ; nerve tube ; sensory outcome