A total of 68 adult and pediatric patients who suffer from at least one discrete partial thickness thermal burn wound (Grade II) will be recruited. Subjects will be randomized (1:1) to either PermeaDerm® or Mepilex Ag®. Evaluations will occur at 7, 14 and 21 days with long term follow-up at 6 and 12 months.
A total of 68 adult and pediatric patients who suffer from at least one discrete partial thickness thermal burn wound (Grade II) will be recruited from the clinical practices of the site Principal Investigators. Participants and/or the Legally Authorized Representative (LAR) as appropriate will be fully informed regarding the conduct of the clinical trial including all potential risks and benefits. All Participants must be consented, randomized (1:1) and treated within 72 hours of injury. It is permissible for a Study Participant to be enrolled if they have more than one burn wound. If more than one partial thickness burn is treated, the Investigator must indicate prior to randomization which wound is to be considered for primary analysis. This wound will be called the Primary Wound and is to be evaluated by a Blinded Assessor. Additional partial thickness wounds must be treated with the same product to which the Study Participant was randomized and will be included in secondary analysis. These wounds are to be described as Secondary Wounds and are to be evaluated by the Unblinded Assessor. Evaluations will occur at 7, 14 and 21 days with long term follow-up at 6 and 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
68
Wound Management Device
Wound Dressing
University of California, Davis
Sacramento, California, United States
RECRUITINGReepithelialization
Time to 100 percent- primary wound
Time frame: 14 days
Alternate therapy
Time to conversion to alternate therapy- primary wound
Time frame: 14 days
Re-epithelialization
Percent reepithelialization primary and secondary Wounds
Time frame: 14 days
Alternate therapy
Time to conversion to alternate therapy- secondary wounds
Time frame: up to 12 Months
Adverse Events
Occurrence, duration, severity, seriousness, expectedness, and relationship of adverse events
Time frame: 21 days
Severity of pain
Wong-Backer Faces pain rating scale and in adults as measured by the Numerical Rating Scale (0-10);
Time frame: Up to 12 Months
Scar characteristics
Patient and Observer Scar Assessment Scale (POSAS)
Time frame: 6 and 12 months
Satisfaction with treatment
Brisbane Burn Scar Impact Profile (BBSIP)
Time frame: 6 and 12 months
Dressing Changes Required
Number
Time frame: Up to 21 Days
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