The purpose of this study is to evaluate the P6 Low Adherent Study Dressing relative to the Standard of Care (SOC, Mafenide Acetate 5% Solution) for the management of skin grafts in burn wounds resulting from thermal burn injuries.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
80
Each patient will have two similar, non-adjacent study sites. One site will be treated with P6 Low Adherent Dressing and the other site will be treated with the Standard of Care (SOC).
Each patient will have two similar, non-adjacent study sites. One site will be treated with P6 Low Adherent Dressing and the other site will be treated with the Standard of Care (SOC).
Shands at University of Florida
Gainesville, Florida, United States
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
University of Tennessee Firefighter's Regional Burn Center
Memphis, Tennessee, United States
Management of skin grafts as determined by investigator's visual assessment of percent graft take
Time frame: 6 days
The incidence of post-operative graft infections
Time frame: 15 days
Assessment of patient's pain / discomfort, using a visual analog scale.
Time frame: 15 days
Costs of study burn site wound dressing regimens.
Time frame: 15 days
Ease of use and clinician preference of the study burn site wound dressing regimens
Time frame: 15 days
Statistical robustness of visual graft take assessments in-person and from digital photographs
Time frame: 15 days
Progression of percent graft take with time for both P6 and SOC.
Time frame: 15 days
Assessment of the incidence and severity of SAEs and wound specific AEs, including local reactions.
Time frame: 15 days
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