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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: 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.

SUBMITTER: Neubrech F

PROVIDER: S-EPMC4727346 | biostudies-literature | 2016 Jan

REPOSITORIES: biostudies-literature

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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.

Neubrech Florian F Heider Sina S Harhaus Leila L Bickert Berthold B Kneser Ulrich U Kremer Thomas T

Trials 20160126

<h4>Background</h4>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.<h4>Methods/design</h4>We pl ...[more]

PMID: 26811067

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Project description:Nerve conduits have become an established option for repair of sensory deficits of up to 2 cm. More recently, decellularized nerve allograft has also been advocated as an option for nerve repair; however, no clinical studies have examined its efficacy for the treatment of sensory nerve defects. The aim of this study was to examine our early experience with the use of decellularized nerve allograft for repair of segmental nerve defects within the hand and fingers. From July 2007 to March 2008, seven patients who had ten nerve gaps were treated surgically using decellularized nerve allograft. Eight digital and two dorsal sensory nerves were repaired. The etiologies of the nerve defects were traumatic nerve transection in eight defects and neuroma resection and reconstruction in two defects. All of the affected nerves were pure sensory fibers. Functional recovery was evaluated by blinded hand therapist using moving and static two point discrimination tests. Implantation sites were also evaluated for any signs of infection, rejection, or graft extrusion. There were five men and two women with a mean age of 44 years (range 23-65). Mean nerve graft length was 2.23 cm with a range of 0.5-3 cm. Mean follow up time was 9 months (range 5-12). Average two point discrimination was 4.4 mm moving and 5.5 mm static at last recorded follow-up. There were no wound infections observed around the graft material and sensory improvement was observed in all of the patients despite this short-term follow-up. Re-exploration of two fingers was required for flexor tendon rupture in one and flexor tendon tenolysis in the other. In both cases, the nerve allograft was visualized and appeared well incorporated in the repair site. Decellularized nerve allografts were capable of returning adequate sensation in nerve defects ranging from 0.5 to 3 cm. There were no cases of infection or rejection. Decellularized nerve allograft may provide an option for segmental nerve gaps beyond 2 cm. Randomized comparative studies will be required to determine efficacy in comparison to collagen conduits or nerve autograft.

Project description:BackgroundNeuroanatomical determinants of motor skill recovery after stroke are still poorly understood. Although lesion load onto the corticospinal tract is known to affect recovery, less is known about the effect of lesions to cortical sensorimotor areas. Here, we test the hypothesis that lesions of somatosensory cortices interfere with the capacity to recover motor skills after stroke.MethodsStandardized tests of motor skill and somatosensory functions were acquired longitudinally over nine months in 29 patients with stroke to the pre- and postcentral gyrus, including adjacent areas of the frontal, parietal and insular cortices. We derived the recovery trajectories of each patient for five motor subtest using least-squares curve fitting and objective model selection procedures for linear and exponential models. Patients were classified into subgroups based on their motor recovery models. Lesions were mapped onto diffusion weighted imaging scans and normalized into stereotaxic space using cost-function masking. To identify critical neuranatomical regions, voxel-wise subtractions were calculated between subgroup lesion maps. A probabilistic cytoarchitectonic atlas was used to quantify of lesion extent and location.ResultsTwenty-three patients with moderate to severe initial deficits showed exponential recovery trajectories for motor subtests that relied on precise distal movements. Those that retained a chronic motor deficit had lesions that extended to the center of the somatosensory cortex (area 2) and the intraparietal sulcus (areas hIP1, hIP2). Impaired recovery outcome correlated with lesion extent on this areas and somatosensory performance. The rate of recovery, however, depended on the lesion load onto the primary motor cortex (areas 4a, 4p).ConclusionsOur findings support a critical role of uni-and multimodal somatosensory cortices in motor skill recovery. Whereas lesions to these areas influence recovery outcome, lesions to the primary motor cortex affect recovery dynamics. This points to a possible dissociation of neural substrates for different aspects of post-stroke recovery.

Dataset Information

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

Publications

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

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