Evaluation of High-Purity Type I Collagen Biologic Wrap to Improve Function After Extensor Tendon… (NCT07335653) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of High-Purity Type I Collagen Biologic Wrap to Improve Function After Extensor Tendon Repair of the Hand
India60 participantsStarted 2025-12-05
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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.
Exclusion criteria
✕. 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).
What they're measuring
1
Total Active Motion (TAM) of Involved Finger(s)
Timeframe: 8 weeks postoperatively
Trial details
NCT IDNCT07335653
SponsorAdichunchanagiri Institute of Medical Sciences, B G Nagara