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.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT02372669 . Protocol Registration Receipt on 27 February 2015.
authors.affiliation: Department of Hand, Plastic and Reconstructive Surgery, Burn Center, BG Trauma Center Ludwigshafen, Plastic- and Hand Surgery, University of Heidelberg, Germany, Ludwig-Guttmann-Str. 13, D-67071, Ludwigshafen, Germany. Florian.Neubrech@bgu-ludwigshafen.de.
authors.forename: Florian
authors.initials: F
authors.lastname: Neubrech
authors.affiliation: Department of Hand, Plastic and Reconstructive Surgery, Burn Center, BG Trauma Center Ludwigshafen, Plastic- and Hand Surgery, University of Heidelberg, Germany, Ludwig-Guttmann-Str. 13, D-67071, Ludwigshafen, Germany. sina_heider@gmx.de.
authors.forename: Sina
authors.initials: S
authors.lastname: Heider
authors.affiliation: Department of Hand, Plastic and Reconstructive Surgery, Burn Center, BG Trauma Center Ludwigshafen, Plastic- and Hand Surgery, University of Heidelberg, Germany, Ludwig-Guttmann-Str. 13, D-67071, Ludwigshafen, Germany. Leila.Harhaus@bgu-ludwigshafen.de.
authors.forename: Leila
authors.initials: L
authors.lastname: Harhaus
authors.affiliation: Department of Hand, Plastic and Reconstructive Surgery, Burn Center, BG Trauma Center Ludwigshafen, Plastic- and Hand Surgery, University of Heidelberg, Germany, Ludwig-Guttmann-Str. 13, D-67071, Ludwigshafen, Germany. Berthold.Bickert@bgu-ludwigshafen.de.
authors.forename: Berthold
authors.initials: B
authors.lastname: Bickert
authors.affiliation: Department of Hand, Plastic and Reconstructive Surgery, Burn Center, BG Trauma Center Ludwigshafen, Plastic- and Hand Surgery, University of Heidelberg, Germany, Ludwig-Guttmann-Str. 13, D-67071, Ludwigshafen, Germany. Ulrich.Kneser@bgu-ludwigshafen.de.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Kneser
authors.affiliation: Department of Hand, Plastic and Reconstructive Surgery, Burn Center, BG Trauma Center Ludwigshafen, Plastic- and Hand Surgery, University of Heidelberg, Germany, Ludwig-Guttmann-Str. 13, D-67071, Ludwigshafen, Germany. Thomas.kremer@bgu-ludwigshafen.de.
authors.forename: Thomas
authors.initials: T
authors.lastname: Kremer
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D048271:Chitosan; D002985:Clinical Protocols; D004311:Double-Blind Method; D006225:Hand / Q000294:innervation*; D018737:Hand Strength; D006801:Humans; D008875:Middle Aged; D059348:Peripheral Nerve Injuries / Q000601:surgery*; D018401:Sample Size
chemical_list: D048271:Chitosan
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