High-Purity Type I Collagen Nerve Wrapping in Peripheral Nerve Procedures: A Prospective Registry

Overview

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.

Peripheral nerve surgery outcomes are often compromised by perineural fibrosis, neuroma formation, and unpredictable axonal regeneration. High-Purity Type I Collagen (HPTC) is a bioengineered resorbable collagen membrane designed to act as a biologic scaffold and perineural barrier, potentially reducing scar adherence and facilitating nerve gliding. This prospective registry enrolls adult patients undergoing peripheral nerve procedures where HPTC is used as an adjunct circumferential nerve wrap. Functional motor recovery, sensory recovery, pain scores, patient-reported outcomes, and complications will be systematically documented at baseline and follow-up intervals up to four months. This registry aims to generate real-world, multicentre evidence regarding the safety and early clinical effectiveness of HPTC nerve wrapping.

Conditions