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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT05084183
Study type Interventional
Source Stedical Scientific, Inc.
Contact Miao Yu, Ph.D
Phone 1-858-753-9530
Email miao.yu@stedical.com
Status Recruiting
Phase N/A
Start date February 2, 2022
Completion date November 2023

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