Dehydrated Human Amnion Chorion Membrane (dHACM) vs. Control in the Treatment of Partial Thickness Burns.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Treatment of Partial Thickness Burns
- Sponsor
- MiMedx Group, Inc.
- Enrollment
- 23
- Locations
- 6
- Primary Endpoint
- Freedom from Scarring
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
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 (partial thickness burns) as assessed by time to healing and scarring
Detailed Description
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
Investigators
Eligibility Criteria
Inclusion 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
Exclusion Criteria
- •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®, Dermagraft®, etc.)
- •Patient criteria that will make patient ineligible for enrollment:
- •Ventilator dependence
- •Active malignant disease or patient is less than 1 year disease-free
Outcomes
Primary Outcomes
Freedom from Scarring
Time Frame: 3 Months
Vancouver Scar Scale: consists of four variables: pliability, vascularity, height (thickness), and pigmentation. Each variable has four to six possible scores. A total score ranges from 0 to 14, whereby a score of 0 reflects normal skin.
Healing Rate
Time Frame: 3 weeks
95% epitheliazation as assesses by the investigator
Secondary Outcomes
- Reduction in pain(3 weeks)