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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
India
Adichunchanagiri Institute of Medical Sciences
RECRUITING
Mandya
Mysore Medical College and Research Institute
RECRUITING
Mysore
Contact Information
Primary
Naveen Narayan, MS, MCh
naveen_uno1@yahoo.co.in
9980023372
Time Frame
Start Date: 2025-12-09
Estimated Completion Date: 2026-03
Participants
Target number of participants: 40
Treatments
Experimental: HPTC Nerve Wrap Arm
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.
Related Therapeutic Areas
Sponsors
Leads: Adichunchanagiri Institute of Medical Sciences, B G Nagara
Collaborators: Mysore Medical College and Research Institute

This content was sourced from clinicaltrials.gov