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RECRUITING
NCT07335653
NA

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

Sponsor: Adichunchanagiri Institute of Medical Sciences, B G Nagara

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-12-05

Completion Date

2026-03

Last Updated

2026-01-14

Healthy Volunteers

No

Interventions

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.

Locations (2)

Adichunchanagiri Institute of Medical Sciences

Mandya, Karnataka, India

Mysore Medical College and Research Institute

Mysore, Karnataka, India