Evaluation of High-Purity Type I Collagen Biologic Wrap to Improve Function After Extensor Tendon Repair of the Hand
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
Adichunchanagiri Institute of Medical Sciences, B G Nagara
60 participants
Dec 5, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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.
Exclusion Criteria9
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
Primary extensor tendon repair using standard core and epitendinous sutures without use of any biologic wrap or anti-adhesion adjunct.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07335653