At a glance
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Prospective Multicentre Registry of High-Purity Type I Collagen Nerve Wrapping in Peripheral Nerve Procedures: Early Clinical Outcomes
In Brief
A clinical study evaluating High-Purity Type I Collagen (HPTC) Nerve Wrap for Peripheral Nerve Injuries and 4 related conditions. Completed, enrolled 40 participants across 2 sites.
Detailed Summary
This prospective multicentre observational registry evaluates early clinical outcomes following the use of High-Purity Type I Collagen (HPTC) as a circumferential nerve wrap during peripheral nerve procedures. Eligible procedures include nerve repair, coaptation, grafting, nerve transfers, and decompressions in the upper and lower limbs. Primary outcomes include early motor recovery assessed using the Medical Research Council (MRC) motor grading system. Secondary outcomes include sensory recovery, neuropathic pain, patient-reported functional outcomes, complication rates, and patient satisfaction assessed at standardized postoperative intervals up to two months.
Study Details
Timeline
Interventions
After completion of nerve repair, coaptation, grafting, transfer, or decompression, a sterile HPTC collagen membrane is hydrated as per manufacturer instructions, trimmed to the length of the treated nerve segment (approximately 1.5-4 cm), and wrapped circumferentially as a loose perineural sleeve. The wrap is secured using fibrin glue or fine absorbable sutures. Standard wound closure and postoperative rehabilitation protocols are followed.