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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Dehydrated human amnion/chorion membrane (dHACM) product and is regulated as a Human Cells, Tissues and Cellular and Tissue Based Product (HCT/P) under Section 361 of the Public Health Service Act by the Food and Drug Administration (FDA).
Arizona Burn Center
Phoenix, Arizona, United States
Keck School of Medicine
Los Angeles, California, United States
University of San Diego Nedical Center
San Diego, California, United States
St Elizabeth Reg Med Center
Lincoln, Nebraska, United States
Healing Rate
95% epitheliazation as assesses by the investigator
Time frame: 3 weeks
Freedom from Scarring
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.
Time frame: 3 Months
Reduction in pain
Visual Analog Scale or FLACC Behavioral Pain Assessment Scale:VAS-No pain on left of line, worst pain imaginable on the right of line; FLACC- 0-2, (0 being least uncomfortable to 2 which is very uncomfortable)
Time frame: 3 weeks
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Bruce Cairns Surgery Burn Center
Chapel Hill, North Carolina, United States
Drexel University
Philadelphia, Pennsylvania, United States