Collagen wrap may help hands heal better after tendon surgery
NCT ID NCT07335653
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
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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
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60 people
The number who actually took part.
- Started
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Dec 2025
- Finished
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Feb 2026
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Adichunchanagiri Institute of Medical Sciences
Mandya, Karnataka, 571448, India
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Mysore Medical College and Research Institute
Mysore, Karnataka, 570001, India