Approximately 55-65 subjects from 3-6 sites suffering from a burn injury covering 1-25% Total Body Surface Area (TBSA) will be evaluated providing they fulfill all inclusion and none of the exclusion criteria and have given a signed and dated informed consent. Study site will be from 1-15%. Each subject will be followed once a week for a maximum of 3 weeks or until the burn is healed if that occurs earlier. All dressing changes will be performed at the clinic and gauze rolls will be used as secondary dressing. All dressing changes will be registered in a dressing log. All subjects will be consecutively allocated to a subject code.
see Brief summary
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.
Arizona Burn Center
Phoenix, Arizona, United States
Orlando Regional Medical Center
Orlando, Florida, United States
Wishard
Indianapolis, Indiana, United States
Paul Silverstein, MD
Oklahoma City, Oklahoma, United States
S:t Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
Harborview Medical Center
Seattle, Washington, United States
Number of Subjects Healed at Day 14.
\> = 95 % epitheliazation
Time frame: Healing will be assessed after 14 days.
Proportion of Subjects Healed at Day 21.
The proportion of subjects healed will be assessed at day 14. Wounds not healed at day 14 will be assessed again at day 21.
Time frame: Healing will be assessed after 21 days.
Percent of Study Burn Healed.
Percent of study burn healed measured by PictZar photo analysis of tissue types.
Time frame: At day 21
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