Chitosan Nerv Tube for Primary Repair of Traumatic Sensory Nerve Lesions of the Hand
NCT ID: NCT02372669
Last Updated: 2017-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2015-03-31
2018-09-30
Brief Summary
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Detailed Description
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This study will enroll participants with traumatic sensory nerve lesions from 3 Centres: Trauma Center Ludwigshafen (Ludwigshafen, Germany), Trauma Center Frankfurt am Main (Frankfurt am Main, Germany) and Trauma Center Bochum (Bochum, Germany). After being informed about the study and its potential risks, patients with traumatic sensory nerve lesions will be consecutively screened for eligibility. The study will be conducted in four successive periods. All enrolled participants will be randomized locally by alternating local lists in the Double-Blind Period. After enrolment, the assigned subject number will be used on all Case Report Forms. The kind of intervention is blinded for the participant and for the investigator of the follow-up that was not involved in surgery. Enrolled participants will be randomized in a 1:1 ratio to primary microsurgical repair with the additional use of a nerve tube, or direct tension free microsurgical repair alone.
Data will be collected in Case Report Forms (CRFs) according to European DIN standard (International Standards Organization (EN ISO) 14155) and Good Clinical Practice recommendations. CRFs will be transmitted electronically to the executive study centre in Ludwigshafen and will be checked there for integrity, quality and consistency. The executive study centre will also ensure standardisation of the registry process, operative procedure and follow-up in all participating centers by periodic monitoring. Furthermore written instructions and a course of instruction will be provided to each Investigator. Data will be collected and analyzed in the executive study centre. There will be also CRFs for reporting drop-outs and for reporting adverse events.
The static 2-point-discrimination (2PD) after 6 months will bet the primary outcome parameter. Assumptions for the gold standard treatment can be made from literature. The mean of 2-PD after 6 months is approximately 8 mm with a standard deviation of 3 mm. A decrease of 2 mm in the 2-PD would be clinically relevant and is assumed for the experimental intervention. Using a 2-sided t-test with a level of 0.05 and a power of 80%, will require 37 patients per group in order to show superiority. The primary endpoint is tested in the per-protocol set (PPS) via an analysis of covariance with centre as factor and distance between lesion and finger pulp as covariate. Secondary objectives will be described without confirmatory analysis. In order to compensate a loss of follow-up or data 50 patients per group will be randomized.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Chitosan
Enrolled participants presenting with traumatic sensory nerve lesions of the hand without defect zone that were randomized to primary microsurgical repair with the additional use of a chitosan nerve tube.
Chitosan nerve tube in addition to gold standard therapy
Primary microsurgical repair of traumatic lesion of sensory nerves of the hand with use of an chitosan nerve tube in addition. Clinical Follow-up will be performed after 3,6,12 and 24 months.
Gold standard Primary microsurgical repair
Primary microsurgical repair of traumatic lesion of sensory nerves of the hand. Clinical Follow-up will be performed after 3,6,12 and 24 months.
Gold standard alone
Enrolled participants presenting with traumatic sensory nerve lesions of the hand without defect zone that were randomized to primary microsurgical repair without the additional use of a chitosan nerve tube.
Gold standard Primary microsurgical repair
Primary microsurgical repair of traumatic lesion of sensory nerves of the hand. Clinical Follow-up will be performed after 3,6,12 and 24 months.
Interventions
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Chitosan nerve tube in addition to gold standard therapy
Primary microsurgical repair of traumatic lesion of sensory nerves of the hand with use of an chitosan nerve tube in addition. Clinical Follow-up will be performed after 3,6,12 and 24 months.
Gold standard Primary microsurgical repair
Primary microsurgical repair of traumatic lesion of sensory nerves of the hand. Clinical Follow-up will be performed after 3,6,12 and 24 months.
Eligibility Criteria
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Inclusion Criteria
* Patient age between 18 an 67 years
* Informed Consent.
Exclusion Criteria
* Known impaired sensibility of the injured finger
* Allergy to chitosan
* Pregnancy
* Immunodeficiency
18 Years
67 Years
ALL
No
Sponsors
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BG Unfallklinik Murnau
OTHER
Responsible Party
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Florian Neubrech
MD
Principal Investigators
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Thomas Kremer, MD
Role: STUDY_CHAIR
BG Unfallklinik Ludwigshafen
Locations
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BG Universitätsklinikum Bergmannsheil Bochum
Bochum, , Germany
BG Unfallklinik Frankfurt
Frankfurt, , Germany
BG Unfallklinik Ludwigshafen
Ludwigshafen, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Kim DH, Han K, Tiel RL, Murovic JA, Kline DG. Surgical outcomes of 654 ulnar nerve lesions. J Neurosurg. 2003 May;98(5):993-1004. doi: 10.3171/jns.2003.98.5.0993.
Konofaos P, Ver Halen JP. Nerve repair by means of tubulization: past, present, future. J Reconstr Microsurg. 2013 Mar;29(3):149-64. doi: 10.1055/s-0032-1333316. Epub 2013 Jan 9.
Lewin-Kowalik J, Marcol W, Kotulska K, Mandera M, Klimczak A. Prevention and management of painful neuroma. Neurol Med Chir (Tokyo). 2006 Feb;46(2):62-7; discussion 67-8. doi: 10.2176/nmc.46.62.
Marcol W, Larysz-Brysz M, Kucharska M, Niekraszewicz A, Slusarczyk W, Kotulska K, Wlaszczuk P, Wlaszczuk A, Jedrzejowska-Szypulka H, Lewin-Kowalik J. Reduction of post-traumatic neuroma and epineural scar formation in rat sciatic nerve by application of microcrystallic chitosan. Microsurgery. 2011 Nov;31(8):642-9. doi: 10.1002/micr.20945. Epub 2011 Oct 18.
Meek MF, Coert JH. Recovery of two-point discrimination function after digital nerve repair in the hand using resorbable FDA- and CE-approved nerve conduits. J Plast Reconstr Aesthet Surg. 2013 Oct;66(10):1307-15. doi: 10.1016/j.bjps.2013.04.058. Epub 2013 Jul 2.
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Simoes MJ, Gartner A, Shirosaki Y, Gil da Costa RM, Cortez PP, Gartner F, Santos JD, Lopes MA, Geuna S, Varejao AS, Mauricio AC. In vitro and in vivo chitosan membranes testing for peripheral nerve reconstruction. Acta Med Port. 2011 Jan-Feb;24(1):43-52. Epub 2011 Feb 28.
Weber RA, Breidenbach WC, Brown RE, Jabaley ME, Mass DP. A randomized prospective study of polyglycolic acid conduits for digital nerve reconstruction in humans. Plast Reconstr Surg. 2000 Oct;106(5):1036-45; discussion 1046-8. doi: 10.1097/00006534-200010000-00013.
Neubrech F, Sauerbier M, Moll W, Seegmuller J, Heider S, Harhaus L, Bickert B, Kneser U, Kremer T. Enhancing the Outcome of Traumatic Sensory Nerve Lesions of the Hand by Additional Use of a Chitosan Nerve Tube in Primary Nerve Repair: A Randomized Controlled Bicentric Trial. Plast Reconstr Surg. 2018 Aug;142(2):415-424. doi: 10.1097/PRS.0000000000004574.
Neubrech F, Heider S, Harhaus L, Bickert B, Kneser U, Kremer T. 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. 2016 Jan 26;17:48. doi: 10.1186/s13063-015-1148-5.
Other Identifiers
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BGU-LU-123
Identifier Type: -
Identifier Source: org_study_id
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