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

Adichunchanagiri Institute of Medical Sciences, B G Nagara

Status: Enrolling

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

Treatments: Device: High-Purity Type I Collagen (HPTC) Nerve Wrap

Study type: Interventional

Funder types: Other

Identifiers

NCT07360730

AIMS/IEC/269/2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 to 70 years
• Patients undergoing peripheral nerve procedures including: Primary nerve repair, Nerve coaptation, Nerve grafting, Nerve transfer, Revision nerve decompression
• Upper or lower limb nerve involvement
• Intraoperative use of HPTC nerve wrap
• Ability to comply with follow-up
• Written informed consent provided

Exclusion criteria

• Active infection at the surgical site
• Known hypersensitivity to collagen products
• Severe uncontrolled systemic illness
• Pregnancy or lactation
• Re-operation at the same nerve site within the previous 6 months
• Inability to provide informed consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

HPTC Nerve Wrap Arm

Experimental group

Description:

Participants undergoing peripheral nerve procedures-including nerve repair, coaptation, grafting, nerve transfer, or decompression-in whom a High-Purity Type I Collagen (HPTC) membrane is used intraoperatively as a circumferential nerve wrap. Outcomes related to motor recovery, sensory recovery, neuropathic pain, complications, and patient-reported functional status are prospectively assessed.

Treatment:

Device: High-Purity Type I Collagen (HPTC) Nerve Wrap