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

RECRUITINGN/ASponsored by Adichunchanagiri Institute of Medical Sciences, B G Nagara
Actively Recruiting
PhaseN/A
SponsorAdichunchanagiri Institute of Medical Sciences, B G Nagara
Started2025-12-09
Est. completion2026-02
Eligibility
Age18 Years – 70 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07360730

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

Age: 18 Years – 70 YearsHealthy volunteers accepted
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

Conditions6

CancerNerve Graft; Complications, MechanicalNeuromaNeuroma of Nerve RepairPeripheral Nerve Decompression InjuryPeripheral Nerve Injuries

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