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

March 25, 2026 updated by: Adichunchanagiri Institute of Medical Sciences, B G Nagara

A Randomized Controlled Trial Evaluating High-Purity Type I Collagen Wrap Around Extensor Tendon Repair Sites in Zones VI-VIII of the Hand to Prevent Adhesions and Improve Functional Outcomes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Extensor tendon injuries of the hand are common due to the superficial location of the tendons and the thin soft tissue envelope over the dorsum of the hand and wrist. These injuries, particularly in zones VI-VIII, are frequently associated with postoperative adhesions and extensor lag, leading to functional impairment and delayed return to work. Postsurgical adhesions may occur in up to 30-40% of tendon injuries and remain a major clinical challenge despite advances in suture techniques and rehabilitation protocols.

Several strategies have been investigated to minimize tendon adhesions, including optimized suture techniques, early mobilization, anti-adhesive agents, and biologic barrier membranes. Recent clinical work has shown that wrapping repaired extensor tendons with an amniotic membrane in zone VI can improve range of motion (ROM), Quick DASH scores, and recovery time, suggesting a true reduction in peritendinous fibrosis. Experimental models have also demonstrated that collagen-glycosaminoglycan (GAG) wraps can reduce early postoperative tendon adhesions while preserving tendon healing strength.

HPTC is a bioengineered, acellular dermal replacement product composed of >97% pure Type I collagen, free of elastin, lipids, and immunogenic proteins. It is manufactured to preserve the native triple helical structure and bioactivity of collagen, providing a cell-conducive scaffold that promotes neovascularization, granulation tissue formation, and tissue remodelling. HPTC is flexible, translucent, moderately tacky, and can be cut, sutured or stapled, making it feasible to be fashioned as a wrap or sleeve around tendons.

Multiple randomized controlled trials and clinical series by Narayan et al. have demonstrated the safety and efficacy of high-purity Type I collagen-based skin substitute HPTC in chronic and acute wounds.

These studies collectively show that high-purity Type I collagen membranes are safe, well tolerated, promote faster wound healing, and have favourable scarring and pain profiles in a variety of clinical settings.

Rationale for the Current Study - Given the strong biological plausibility of Type I collagen scaffolds as biocompatible, resorbable barriers that can modulate the healing milieu; the safety and clinical efficacy of HPTC in multiple wound types; and the demonstrated benefit of biologic wraps (e.g., amniotic membrane) around extensor tendon repairs in reducing adhesions, it is logical to evaluate whether a HPTC wrap around the repaired extensor tendon in zones VI-VIII can reduce adhesion-related stiffness and improve functional outcomes compared with standard repair alone.

This trial will be, to our knowledge, the first prospective randomized clinical trial to assess HPTC as a tendon wrap in extensor tendon repairs of the hand.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Mandya, Karnataka, India, 571448
        • Adichunchanagiri Institute of Medical Sciences
      • Mysore, Karnataka, India, 570001
        • Mysore Medical College and Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18-65 years.
  2. 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.
  3. Complete tendon laceration (≥50% tendon cross-sectional area), requiring primary repair.
  4. Time from injury to surgical repair ≤72 hours.
  5. Single upper limb involved.
  6. Ability and willingness to comply with postoperative rehabilitation protocol and follow-up visits.
  7. Provision of written informed consent.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: HPTC Wrap + Standard Extensor Tendon Repair
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
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.
Procedure: Standard Extensor Tendon Repair
Primary extensor tendon repair using standard core and epitendinous sutures without use of any biologic wrap or anti-adhesion adjunct.
Other: Standard Extensor Tendon Repair Alone
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
Primary extensor tendon repair using standard core and epitendinous sutures without use of any biologic wrap or anti-adhesion adjunct.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Active Motion (TAM) of Involved Finger(s)
Time Frame: 8 weeks postoperatively
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Return to Work or Activities of Daily Living
Time Frame: Up to 8 weeks postoperatively
Number of days from surgery to return to pre-injury occupational or activities of daily living status.
Up to 8 weeks postoperatively
QuickDASH Score
Time Frame: 6 weeks and 8 weeks postoperatively
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire assessing upper limb disability and symptoms. Lower scores indicate better function. Higher scores indicate greater impairment. Score Range 0 to 100.
6 weeks and 8 weeks postoperatively
Extensor Lag
Time Frame: 8 weeks postoperatively
Extensor lag was calculated as the total extension deficit (in degrees) across the metacarpophalangeal (MCP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints of the involved finger(s). The deficits at each joint were summed to generate a single total extensor lag value. Lower values indicate better functional outcome.
8 weeks postoperatively
Number of Participants With Clinically Significant Tendon Adhesions
Time Frame: Up to 8 weeks postoperatively
Number of participants who developed clinically significant tendon adhesions within 8 weeks postoperatively. Clinically significant adhesion was defined as failure to achieve Total Active Motion (TAM) ≥60% of the contralateral digit despite adherence to rehabilitation protocol and/or requirement for surgical tenolysis. Higher values indicate greater frequency of adhesion-related complications.
Up to 8 weeks postoperatively
Grip Strength
Time Frame: 8 weeks postoperatively
Grip strength measured using a calibrated Jamar dynamometer and expressed as a percentage of the contralateral uninvolved side. Higher values indicate better functional recovery.
8 weeks postoperatively
Patient Satisfaction
Time Frame: 8 weeks postoperatively
Patient-reported satisfaction with hand function and appearance measured using Likert scale. Scale range: 1 to 10 (1 = very dissatisfied, 10 = very satisfied). Interpretation: Higher scores indicate greater patient satisfaction.
8 weeks postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adichunchanagiri Institute of Medical Sciences, B G Nagara

Collaborators

Mysore Medical College and Research Institute

Investigators

  • Study Chair: Prema Dhanraj, MS, MCh, Rajarajeshwari Medical College and Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2025

Primary Completion (Actual)

February 21, 2026

Study Completion (Actual)

February 26, 2026

Study Registration Dates

First Submitted

January 2, 2026

First Submitted That Met QC Criteria

January 2, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIMS/IEC/270/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) underlying the results reported in the primary and secondary outcome analyses will be shared. This includes demographic variables, injury characteristics, intervention allocation, Total Active Motion (TAM) measurements, QuickDASH scores, extensor lag measurements, grip strength values, complication data, and time-to-return-to-work variables. Data dictionaries and metadata necessary to interpret the shared datasets will also be provided.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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