N/A N=40 Treatment

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

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

Bottom Line

View on ClinicalTrials.gov: NCT07360730 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2026

Primary outcome: Primary: Motor Functional Recovery (MRC Grade ≥ M3) — 34 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: High-Purity Type I Collagen (HPTC) Nerve Wrap (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Adichunchanagiri Institute of Medical Sciences, B G Nagara
Primary completion: Feb 2026

Outcome Measures

Outcome	Result	p-value
PRIMARY Motor Functional Recovery (MRC Grade ≥ M3)	34	—
PRIMARY Sensory Recovery - Two-Point Discrimination	8.6	—
PRIMARY Number of Participants With Sensory Recovery Assessed by Semmes-Weinstein Monofilament Testing	27	—
SECONDARY Neuropathic Pain Intensity	6.8; 5.0; 2.4	—
SECONDARY Upper Limb Patient-Reported Functional Outcome (QuickDASH)	58.2; 31.4	—
SECONDARY Lower Limb Patient-Reported Functional Outcome (LEFS)	53.7; 68.9	—
SECONDARY Patient Satisfaction	34; 4; 2	—

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 Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT07360730). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.