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

NCT07360730 | Completed Results

• 1 other identifier: AIMS/IEC/269/2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Motor Functional Recovery (MRC Grade ≥ M3)

  Motor recovery of the involved muscle groups assessed using the Medical Research Council (MRC) Motor Grading system. Successful recovery was defined as achievement of MRC grade ≥ M3, representing active movement against gravity.

  2 months post-operative

• Sensory Recovery - Two-Point Discrimination

  Sensory recovery assessed using two-point discrimination testing in the affected nerve distribution, measured as the minimum distance (in millimeters) at which two points are perceived as separate.

  2 months post-operative

• Number of Participants With Sensory Recovery Assessed by Semmes-Weinstein Monofilament Testing

  Number of participants demonstrating sensory recovery as assessed by Semmes-Weinstein monofilament testing at 2 months postoperatively. Sensory recovery was defined as the ability to perceive a clinically meaningful monofilament threshold in the affected nerve distribution. Higher values indicate greater proportion of participants achieving sensory recovery.

  2 months post-operative

Secondary Outcomes (4)

• Neuropathic Pain Intensity

  Baseline, 1 month, and 2 months post-operative

• Upper Limb Patient-Reported Functional Outcome (QuickDASH)

  1 month and 2 months post-operative

• Lower Limb Patient-Reported Functional Outcome (LEFS)

  1 month and 2 months post-operative

• Patient Satisfaction

  2 months post-operative

Study Arms (1)

HPTC Nerve Wrap Arm

EXPERIMENTAL

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.

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

Interventions

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

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.

HPTC Nerve Wrap Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adichunchanagiri Institute of Medical Sciences, B G Nagara: lead
• Mysore Medical College and Research Institute: collaborator

Study Sites (2)

Adichunchanagiri Institute of Medical Sciences

Mandya, Karnataka, 571448, India

Location

Mysore Medical College and Research Institute

Mysore, Karnataka, 570001, India

Location

Related Publications (10)

• Klein S, Vykoukal J, Felthaus O, Dienstknecht T, Prantl L. Collagen Type I Conduits for the Regeneration of Nerve Defects. Materials (Basel). 2016 Mar 23;9(4):219. doi: 10.3390/ma9040219.

  PMID: 28773346 BACKGROUND

• Kokkalis ZT, Mavrogenis AF, Ballas EG, Papagelopoulos PJ, Soucacos PN. Collagen nerve wrap for median nerve scarring. Orthopedics. 2015 Feb;38(2):117-21. doi: 10.3928/01477447-20150204-04.

  PMID: 25665110 BACKGROUND

• Tanaka H, Kurimoto S, Hirata H. Efficacy of collagen conduit wrapping with collagen fibers on nerve regeneration in sciatic nerve injury with partial transection: An experimental study in the rat model. J Biomed Mater Res B Appl Biomater. 2024 Jan;112(1):e35369. doi: 10.1002/jbm.b.35369.

  PMID: 38247253 BACKGROUND

• Narayan N, Shivannaiah C, Gowda S. Evaluating the Efficacy of High-Purity Type I Collagen-Based Skin Substitute Versus Dehydrated Human Amnion/Chorion Membrane in the Treatment of Venous Leg Ulcers: A Randomized Controlled Clinical Trial. Cureus. 2025 Jul 30;17(7):e89031. doi: 10.7759/cureus.89031. eCollection 2025 Jul.

  PMID: 40747200 BACKGROUND

• Narayan N, Ramegowda YH, Raghupathi DS, Chethan S, Gowda S. Biological Skin Substitutes in Pressure Ulcers: High-Purity Type I Collagen-Based Versus Amnion/Chorion Membrane. Cureus. 2025 Aug 25;17(8):e90956. doi: 10.7759/cureus.90956. eCollection 2025 Aug.

  PMID: 40862036 BACKGROUND

• Narayan N, Shivaiah R, Kumar V, Kumar KM, Chethan S, Gowda S. Comparative Efficacy of High Purity Type I Collagen-Based Skin Substitute and Dehydrated Human Amnion/Chorion Membrane in Diabetic Foot Ulcers: A Multicentre Randomized Controlled Trial. Cureus. 2025 Oct 19;17(10):e94952. doi: 10.7759/cureus.94952. eCollection 2025 Oct.

  PMID: 41122365 BACKGROUND

• Narayan N, Raghupathi D, Ramamurthy V, Chethan S, Gowda S. A Comparative Analysis in the Treatment of Full-Thickness Wounds: Negative-Pressure Wound Therapy (NPWT) Combined With High-Purity Type I Collagen-Based Skin Substitute Versus NPWT Alone. Cureus. 2025 Nov 16;17(11):e96977. doi: 10.7759/cureus.96977. eCollection 2025 Nov.

  PMID: 41250786 BACKGROUND

• Lee S, Ahmad A, Jeon G. Combining Bootstrap Aggregation with Support Vector Regression for Small Blood Pressure Measurement. J Med Syst. 2018 Feb 28;42(4):63. doi: 10.1007/s10916-018-0913-x.

  PMID: 29488105 BACKGROUND

• Mayrhofer-Schmid M, Klemm TT, Aman M, Kneser U, Eberlin KR, Harhaus L, Boecker AH. Shielding the Nerve: A Systematic Review of Nerve Wrapping to Prevent Adhesions in the Rat Sciatic Nerve Model. J Pers Med. 2023 Sep 24;13(10):1431. doi: 10.3390/jpm13101431.

  PMID: 37888042 BACKGROUND

• Radecka W, Nogalska W, Siemionow M. Peripheral Nerve Protection Strategies: Recent Advances and Potential Clinical Applications. J Funct Biomater. 2025 Apr 24;16(5):153. doi: 10.3390/jfb16050153.

  PMID: 40422818 BACKGROUND

MeSH Terms

Conditions

Peripheral Nerve Injuries; Neuroma

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms

Limitations and Caveats

The absence of a control group limits causal inference, and the sample size restricts detailed subgroup analysis. Lack of blinding may have introduced performance and reporting bias. Follow-up was limited to early postoperative outcomes up to two months, precluding assessment of long-term functional recovery and late complications.

Results Point of Contact

• Title: Prof Naveen Narayan
• Organization: Adichunchanagiri Institute of Medical Sciences

naveen_uno1@yahoo.co.in

+91-9980023372

Study Officials

• Prema Dhanraj, MS, MCh

  Rajarajeshwari Medical College and Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 22, 2026
• Study Start: December 9, 2025
• Primary Completion: February 26, 2026
• Study Completion: March 3, 2026
• Last Updated: March 30, 2026
• Results First Posted: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be made available beginning 6 months after publication of the primary study results and will remain available for up to 5 years following publication.
• Access Criteria: Access to the de-identified IPD will be granted to qualified researchers who submit a methodologically sound research proposal. Requests will be reviewed by the principal investigator and study steering committee. Data will be shared under a data-sharing agreement to ensure protection of participant confidentiality.

Locations

IN (2)