NCT02372669.
Study name | Chitosan nerve tube for primary repair of traumatic sensory nerve lesions of the hand (CNT) |
Methods | To evaluate whether the additional use of a chitosan nerve tube in primary microsurgical repair of traumatic sensory nerve lesions of the hand has an effect on convalescence and functional results. |
Participants | Adults aged 18–67 years with a sensory nerve defect in the hand |
Interventions | Chitosan nerve tube Gold‐standard repair |
Outcomes | Static 2‐PD of injured finger measured with compasses 6 months after intervention (primary outcome) Static 2‐PD of injured finger/sensibility (checking participants' ability to recognise filaments of different calibres) at other follow‐ups (3, 6, 12, and 24 months after intervention). DASH‐score (at 3, 6, 12, and 24 months after intervention). Patients' individual disability in activities of daily living will be measured with the DASH questionnaire. Grip strength (at 3, 6, 12, and 24 months after intervention). Grip strength of both hands will be measured with a dynamometer and will be compared to the opposite side. Range of motion of the injured finger (at 3, 6, 12, and 24 months after intervention). Range of motion of the injured finger measured with a goniometer for small joints and will be compared to the opposite side. Pain (VAS) (at 3, 6, 12, and 24 months after intervention). Participants will self‐report pain on VAS, ranged from 0 (no pain) up to 10 (maximum of pain) Cold intolerance (grades: 0 = hinders function; 1 = disturbing; 2 = moderate; 3 = none/minor) (at 3, 6, 12, and 24 months after intervention). The examiner will question the participant about cold intolerance (grades: 0 = hinders function; 1 = disturbing; 2 = moderate; 3 = none/minor) Hypersensitivity (grades: 0 = hinders function; 1 = disturbing; 2 = moderate; 3 = none/minor) (at 3, 6, 12, and 24 months after intervention). The examiner will stroke the dysfunctional area and question the participant about cold hypersensitivity (grades: 0 = hinders function; 1 = disturbing; 2 = moderate; 3 = none/minor) Existence of neuromas (at 3, 6, 12, and 24 months after intervention). The existence of a neuroma will be assessed clinically and by neurosonography. |
Starting date | 1 July 2015 |
Contact information | florian.neubrech@bgu‐ludwigshafen.de |
Notes |
2‐PD: 2‐point discrimination; DASH: Disabilities of the Arm, Shoulder and Hand; EQ‐5D: Euro‐Qol 5 Dimension; PEG: polyethylene glycol; VAS: visual analogue scale; WESY: Weinstein Enhanced Sensory Test.