OPEN Study
Research type
Research Study
Full title
Novel Outcome measures in Peripheral Nerve injury (OPEN Study)
IRAS ID
236388
Contact name
Adam Reid
Contact email
Sponsor organisation
University of Manchester
Clinicaltrials.gov Identifier
ISRCTN17886637
Clinicaltrials.gov Identifier
Funded Reference, R119224
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
OPEN Study
Aiming to improve treatment for patients with nerve injuries by improving how we measure nerve regrowth and repair.
Peripheral nerve injuries result in a loss of sensation to crucial areas of the hand. Alongside this, there is a loss of sweating and changes to the skin of the affected area. This study aims to assess whether it is possible to assess these skin changes in nerve injured patients in order to examine if they can be used to monitor recovery of sensation in patients who have undergone treatment. These changes will be measured using OCT (Optical Coherence Tomography) imaging, a non-invasive device.
In addition to changes in the skin we aim to investigate whether detailed three-dimensional ultrasound (similar to pregnancy scans) can be used to monitor nerve regeneration at the operation repair site. This imaging tool is non-invasive can be used to determine how fast the nerve is re-growing and also the volume of the re-growing nerve.
Adult patients over 18-years old who are attending Wythenshawe Hospital, Department of Plastic Surgery with a nerve injury in their forearm will be offered the opportunity to take part in this research.
The research will last 12-months after participants' initial surgery and there will be no effect on their normal care pathway or surgery.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
18/EM/0426
Date of REC Opinion
25 Jan 2019
REC opinion
Further Information Favourable Opinion