Placental membrane may speed burn healing in new clinical trial

NCT ID NCT07489560

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This study tests whether a special placental tissue dressing (AmCoreMatrix Burn) helps second-degree burns heal faster than standard care. About 70 adults with burns covering 5-15% of their body will take part. The main goal is to see how quickly the burn skin fully closes.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

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.

Ages

18 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: * 18 years of age or older * One or more thermal burns classified as either superficial partial thickness or deep partial thickness. * Total Body Surface Area (TBSA) involvement between 5% and 15%. * Total burn index wound area is greater than 25 cm 2 and less than 0.25 m 2 (2500 cm 2 ) * 1 If 2 or more burns are present, each must have an area greater than 15 cm 2 * The participant must be willing and able to participate in the informed consent process. Exclusion Criteria: * Full thickness burns. * Burns present for \>72 hours prior to study evaluation * Burns requiring immediate autografting. * Superficial burns (1 st -degree) or burns not meeting criteria to be included in TBSA calculations. * Chemical or electrical burns. * Burns secondary to blast injury. * Burns causing vascular or respiratory compromise and burns requiring escharotomy * Any severe systemic comorbidities which could impair healing (e.g. active sepsis or major organ failure). * Known coagulopathy, platelet disorder, INR \> 1.6, PTT \> 38s, or platelets \< 50,000 per mm 3 * Uncontrolled diabetes. * Known life expectancy of \< 6 months. * Evidence of active infection in burn. * Target area for treatment includes the head, neck, palms of hands, soles of the feet, or genitals. * Viral infection which could impair healing or immune function (e.g. HIV, HBV, HCV) * Participants of childbearing potential who are pregnant, considering becoming pregnant within the next 6 months, and/or are unwilling to utilize an appropriate form of contraception. * Currently requiring dialysis or planning to start within 6 months. * Medical or psychological condition that, in the opinion of the investigator, may interfere with study assessments. * Treated with hyperbaric oxygen therapy or a skin substitute within the 30 days prior to screening visit. * Sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics. * Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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