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Study of burn scar healing pulled before it began

NCT ID NCT06760611

Knowledge-focused Sponsor: Integra LifeSciences Corporation Source: ClinicalTrials.gov ↗

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 21, 2026 · Updated 2 times

Summary

This study was designed to observe and compare the quality of burn scars in people treated with two different skin substitutes—Integra and NovoSorb BTM—12 to 36 months after their final skin graft. Researchers planned to review medical records, use non-invasive scar measurements, and ask patients about their outcomes. However, the study was withdrawn before enrolling any participants, so no results are available.

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.

Expected to start

Mar 2025

An estimate. Start dates often move.

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

This study aims to enroll a total of up to 60 subjects, with 25 unique patients in the Integra-treated burns cohort 25 unique patients in the BTM-treated burns cohort, and up to 10 unique patients in the combination arm

Ages

21 years and older

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. Patient has reviewed the IRB-approved consent form, has been properly consented per the protocol and has documented their consent to participate in the study by signing the IRB-approved consent form. 2. Patient had a deep dermal or full-thickness burn that required skin grafting that was first treated with Integra\* or BTM, and at least 70% 'take' followed by an autograft 3. Patient had final skin graft between 12-36 months prior enrollment in the study. 4. Burn must have been ≥10% total body surface area (TBSA) and ≤70% TBSA. 5. Patient is ≥ 21 years of age at the time of treatment. Exclusion Criteria: 1. Patient had a radiation burn. 2. Patient was treated with Integra or BTM and closed via secondary intention. 3. Severe cognitive dysfunction or psychiatric disorders. 4. Immunocompromised patients.

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Conditions

The condition(s) this trial relates to.

burn

As listed by the trial registrant

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

Burn injury Burn scar Burn wounds - partial thickness (2ND degree) Skin grafting

More trials for these conditions

Other studies related to the condition(s) this trial covers.