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Collagen wrap may help hands heal better after tendon surgery

NCT ID NCT07335653

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether wrapping a repaired hand tendon with a special collagen sheet could prevent scar tissue from forming and improve hand movement. Sixty adults with cut extensor tendons in their hand or wrist were randomly assigned to get either standard tendon repair alone or repair plus the collagen wrap. The main goal was to measure how much the fingers could move after healing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
High-Purity Type I Collagen (HPTC) Wrap
What this could lead to
If it works, this collagen wrap could reduce scarring and stiffness after hand tendon repair, helping people regain better hand movement and function.
What could go wrong
This is a small, completed trial with only 60 participants. The collagen wrap is a device, not a drug, and its benefits may not be large or apply to all tendon injuries. There is always a risk of infection or poor healing with any surgical implant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

60 people

The number who actually took part.

Started

Dec 2025

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Hand Injuries

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Adichunchanagiri Institute of Medical Sciences

    Mandya, Karnataka, 571448, India

  • Mysore Medical College and Research Institute

    Mysore, Karnataka, 570001, India