NCT07360730

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

Prospective Multicentre Registry of High-Purity Type I Collagen Nerve Wrapping in Peripheral Nerve Procedures: Early Clinical Outcomes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Adichunchanagiri Institute of Medical Sciences, B G Nagara · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

• Peripheral Nerve Injuries
• Neuroma of Nerve Repair
• Nerve Graft; Complications, Mechanical
• Peripheral Nerve Decompression Injury
• Neuroma

Interventions

Type	Name	Description
DEVICE	High-Purity Type I Collagen (HPTC) Nerve Wrap	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.

Timeline

• Start date: 2025-12-09
• Primary completion: 2026-02-26
• Completion: 2026-03-03
• First posted: 2026-01-22
• Last updated: 2026-03-30
• Results posted: 2026-03-30

Locations

2 sites across 1 country: India