Clinical trial · Interventional
High-Purity Type I Collagen Nerve Wrapping in Peripheral Nerve Procedures: A Prospective Registry
Prospective Multicentre Registry of High-Purity Type I Collagen Nerve Wrapping in Peripheral Nerve Procedures: Early Clinical Outcomes
NCT07360730CI-TRIAL-00106799completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nerve Graft; Complications, Mechanical | — | UNRESOLVED | — |
| Neuroma | — | UNRESOLVED | — |
| Neuroma of Nerve Repair | — | UNRESOLVED | — |
| Peripheral Nerve Decompression Injury | — | UNRESOLVED | — |
| Peripheral Nerve Injuries | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High-Purity Type I Collagen (HPTC) Nerve Wrap | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HPTC Nerve Wrap Arm
- 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.
- interventionNames
- Device: High-Purity Type I Collagen (HPTC) Nerve Wrap
Primary outcomes (3)
- measure
- Motor Functional Recovery (MRC Grade ≥ M3)
- timeFrame
- 2 months post-operative
- description
- 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.
- measure
- Sensory Recovery - Two-Point Discrimination
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (10)
- BACKGROUNDKlein 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
- BACKGROUNDKokkalis 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
- BACKGROUNDTanaka 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
- BACKGROUNDNarayan 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
- BACKGROUNDNarayan 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
- BACKGROUNDNarayan 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
- BACKGROUNDNarayan 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.