Evaluation of High-Purity Type I Collagen Biologic Wrap to Improve Function After Extensor Tendon Repair of the Hand

NCT07335653 | Completed Results

• 1 other identifier: AIMS/IEC/270/2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Tendon injuries of the hand, particularly extensor tendons, are prone to postoperative adhesions, extensor lag, and stiffness, leading to functional impairment. This multicentric randomized controlled trial evaluates whether wrapping repaired extensor tendons with a high-purity Type I collagen (HPTC) biologic membrane can reduce adhesion formation and improve functional outcomes compared with standard repair alone.

Conditions

Tendon Adhesions; Injury of Extensor Tendon of Hand

Keywords

Extensor tendon repair; Tendon adhesion; High Purity Type I Collagen; Biologic wrap; Hand injuries

Outcome Measures

Primary Outcomes (1)

• Total Active Motion (TAM) of Involved Finger(s)

  Total Active Motion (TAM) is calculated as the sum of active flexion at the metacarpophalangeal (MCP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints minus the extension deficits. TAM is expressed in degrees. Higher values indicate better functional outcome.

  8 weeks postoperatively

Secondary Outcomes (6)

• QuickDASH Score

  6 weeks and 8 weeks postoperatively

• Extensor Lag

  8 weeks postoperatively

• Number of Participants With Clinically Significant Tendon Adhesions

  Up to 8 weeks postoperatively

• Grip Strength

  8 weeks postoperatively

• Time to Return to Work or Activities of Daily Living

  Up to 8 weeks postoperatively

Study Arms (2)

HPTC Wrap + Standard Extensor Tendon Repair

ACTIVE COMPARATOR

After completion of standard extensor tendon repair, a sterile high-purity Type I collagen sheet is hydrated, trimmed, and loosely wrapped circumferentially around the repaired tendon segment to act as a resorbable biologic barrier aimed at reducing peritendinous adhesions.

Device: High-Purity Type I Collagen (HPTC) Wrap; Procedure: Standard Extensor Tendon Repair

Standard Extensor Tendon Repair Alone

OTHER

Primary extensor tendon repair using standard core and epitendinous sutures without use of any biologic wrap or anti-adhesion adjunct.

Procedure: Standard Extensor Tendon Repair

Interventions

Standard Extensor Tendon Repair PROCEDURE

Primary extensor tendon repair using standard core and epitendinous sutures without use of any biologic wrap or anti-adhesion adjunct.

HPTC Wrap + Standard Extensor Tendon Repair; Standard Extensor Tendon Repair Alone

High-Purity Type I Collagen (HPTC) Wrap DEVICE

After completion of standard extensor tendon repair, a sterile high-purity Type I collagen sheet is hydrated, trimmed, and loosely wrapped circumferentially around the repaired tendon segment to act as a resorbable biologic barrier aimed at reducing peritendinous adhesions.

HPTC Wrap + Standard Extensor Tendon Repair

Eligibility Criteria

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

You may qualify if:

• Age 18-65 years.
• Acute open laceration of extensor tendons in zone VI, VII, or VIII of the hand / wrist (according to Verdan's classification), involving digits 2-5 and/or wrist extensors.
• Complete tendon laceration (≥50% tendon cross-sectional area), requiring primary repair.
• Time from injury to surgical repair ≤72 hours.
• Single upper limb involved.
• Ability and willingness to comply with postoperative rehabilitation protocol and follow-up visits.
• Provision of written informed consent.

You may not qualify if:

• Crush, avulsion, or segmental tendon loss requiring graft or tendon transfer.
• Associated open fractures requiring dorsal plating across the repair site, or extensive bone loss affecting joint stability.
• Previous surgery or significant scarring over the injured extensor tendon region.
• Associated major nerve injury requiring graft or complex reconstruction (digital nerve repair without grafting may be allowed if balanced between groups).
• Uncontrolled systemic illness (e.g., HbA1c \> 8.5% for diabetes, severe peripheral vascular disease, chronic steroid use, severe malnutrition).
• Active infection at the injury site.
• Known allergy or hypersensitivity to bovine/ovine collagen or any component of HPTC.
• Pregnancy or lactation.
• Inability to provide informed consent or comply with follow-up.

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)

• 15. Wong JKF, Metcalfe AD, Wong R, Bush J, Platt C, McGrouther DA. Reduction of tendon adhesion formation with a collagen-GAG scaffold: an experimental study. J Hand Surg Eur Vol. 2006;31(2):143-150.

  BACKGROUND

• Moran SL, Ryan CK, Orlando GS, Ehara K, Hentz VR. Effects of anti-adhesion barriers on the healing of repaired extensor digitorum communis tendons in a rabbit model. J Hand Surg Am. 2000;25(3):546-553.

  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

• 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, 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, 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

• Wong JK, Lui YH, Kapacee Z, Kadler KE, Ferguson MW, McGrouther DA. The cellular biology of flexor tendon adhesion formation: an old problem in a new paradigm. Am J Pathol. 2009 Nov;175(5):1938-51. doi: 10.2353/ajpath.2009.090380. Epub 2009 Oct 15.

  PMID: 19834058 BACKGROUND

• Al-Qattan MM. Controlled active motion following extensor tendon repair in zones V-VIII. J Hand Surg Br. 2005;30(2):166-169.

  BACKGROUND

• VERDAN CE. Primary repair of flexor tendons. J Bone Joint Surg Am. 1960 Jun;42-A:647-57. No abstract available.

  PMID: 13855215 BACKGROUND

• Newport ML, Blair WF, Steyers CM Jr. Long-term results of extensor tendon repair. J Hand Surg Am. 1990 Nov;15(6):961-6. doi: 10.1016/0363-5023(90)90024-l.

  PMID: 2269792 BACKGROUND

MeSH Terms

Conditions

Hand Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Limitations and Caveats

The follow-up period was limited to eight weeks, which may not fully capture long-term tendon gliding, late adhesion formation, or need for secondary procedures such as tenolysis.

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: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 13, 2026
• Study Start: December 5, 2025
• Primary Completion: February 21, 2026
• Study Completion: February 26, 2026
• Last Updated: April 13, 2026
• Results First Posted: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be available beginning 6 months after publication of the primary study results and will remain available for a period of 5 years following publication.
• Access Criteria: IPD will be shared with qualified researchers who submit a methodologically sound research proposal and agree to the terms of data use. IPD may be used for meta-analyses, secondary analyses, methodological research, or validation studies related to tendon repair outcomes and adhesion prevention strategies. Data will be shared upon reasonable request through secure institutional data-sharing platforms or encrypted electronic transfer after execution of a data use agreement (DUA). All shared data will be fully de-identified to protect participant confidentiality, in accordance with applicable ethical and regulatory guidelines.

Locations

IN (2)