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. 2022 Dec 7;2022(12):CD012574. doi: 10.1002/14651858.CD012574.pub2

ISRCTN97234566.

Study name CoNNECT: a study of sutureless nerve repair
Methods Interventional 3‐arm RCT powered for equivalence. Computer randomisation. Participants and observers blinded.
Participants Patients aged 16–75 years with a traumatic complete digital nerve injury between the wrist and middle of the affected finger < 10 days old
Interventions Stitching injured nerve ends directly together
Stitching nerve ends directly together and placing a nerve conduit around it
Placing the injured nerve ends together without stitches and using the nerve conduit to maintain their position and heal
Outcomes Primary outcome measure
Sensory recovery using static and moving 2‐PD (tactile gnosis) for each repaired nerve. The comparable area on the opposite hand will be tested for static and moving 2‐PD to act as a baseline for assessment of recovery. These measurements will allow the modified Weber score to be calculated. This will be assessed at weeks 2, 6, 12, 26, and 52.
Secondary outcome measures
Monofilament pressure thresholds (innervation density), assessed using the WEST Monofilaments
Upper extremity disability and symptoms, assessed using the DASH score
Self‐rated health, assessed using the EQ‐5D
Nerve irritation, assessed using differential Tinel's sign
Pain, assessed using a VAS
Cold intolerance, assessed using a VAS
Hyperaesthesia, assessed using a VAS
Site of repair, measured in mm from the hyponychium of the same digit (the duration of each repair will be recorded)
For suture repairs, the quality of the repair will be recorded using the visual grading scale for suture‐only nerve repair
For common digital nerve repair, the outcome for each digital nerve territory will be recorded
Each assessed at weeks 2, 6, 12, 26, and 52
Starting date 1 February 2017
Contact information dominic.power@uhb.nhs.uk
Notes Retrospectively registered