NCT05084183

Evaluation of the Effectiveness of PermeaDerm® (PD) as Compared to Mepilex Ag®

An Adaptive, Randomized, Controlled Trial Evaluating the Effectiveness of PermeaDerm® (PD) as Compared to Mepilex Ag® Used as Standard of Care in the Treatment of Adult and Pediatric Partial Thickness Burns.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Stedical Scientific, Inc. · Industry
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Thermal Burn

Interventions

Type	Name	Description
DEVICE	PermeaDerm®	Wound Management Device
DEVICE	Mepilex Ag	Wound Dressing

Timeline

• Start date: 2022-02-02
• Primary completion: 2022-11-01
• Completion: 2023-11-01
• First posted: 2021-10-19
• Last updated: 2022-06-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study