Placental membrane may speed burn healing in new clinical trial
NCT ID NCT07489560
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- 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: * 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
The condition terms exactly as the trial's registrant entered them.
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