Dehydrated Human Amnion Chorion Membrane (dHACM) vs. Control in the Treatment of Partial Thickness Burns.
Description
Brief Summary
Multicenter, prospective, randomized, controlled feasibility trial to determine the safety
and effectiveness of Dehydrated Human Amnion Chorion Membrane (dHACM) plus Control as
compared to Control alone for the treatment of second degree burns as assessed by time to
healing and scarring
Phase
OtherInclusion and Exclusion Criteria
- ll patients enrolled must meet all the following criteria:
- Patient with burn injury that meets all of the following requirements:
- Occurred within the last 48 hours
- Wound is thermal in nature
- Partial-thickness burn (burn extends through the epidermis and may penetrate into the dermis)
- Total body surface area (TBSA) of burn(s) is 2-20% for all subjects
- Burn area(s) located on smooth, flat surface
- 2 burn areas, each with a minimum size of 16cm2 (burn areas may be two separate burns or within one large burn, see Section 9.4.2)
- Age ≥ 12 months and ≤ 70 years
- Subjects meeting any of the following criteria will be excluded:
- Burns meeting any of the following criteria:
- Mechanism of injury was electrical, radiation, chemical or frostbite
- Wound is larger than 200 cm2
- Clinically infected burn (as judged by the investigator)
- Previous or planned treatment of the Burn Area(s) with any of the following: - Biological Skin Substitutes (including Apligraf
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
Powered by
SC CTSI