NCT03613870

PermeaDerm® vs. Mepilex-Ag® in Promoting Healing of Partial-thickness Burn Wounds

A Prospective, Randomized, Parallel Study to Evaluate the Effectiveness of PermeaDerm® and Mepilex-Ag® in Promoting Healing of Partial-thickness Burn Wounds

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: All
• Age: 6 Months – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the effectiveness of the wound dressings currently used at our institution for partial-thickness burn wounds: PermeaDerm® (PermeaDerm, Inc., Carlsbad, California, USA) and silver impregnated foam dressing (Mepilex Ag®, Health Care, Göteborg, Sweden)

Detailed description

In this prospective, randomized parallel study, the effectiveness of the wound dressings currently used at our institution for partial-thickness burn wounds will be compared: PermeaDerm®, and silver coated foam dressing Mepilex Ag®.This study is therefore considered a minimal risk study. Procedures related to research apart from randomization to one of the dressings, will include review of medical records, non-invasive wound and scar assessments and additional photographs. 60 patients with partial thickness burns meeting the inclusion criteria of the study will be enrolled to receive either PermeaDerm® (n=30) or silver coated foam dressing (Mepilex Ag®; n=30) in an outpatient or observational setting. Prior to placement of wound dressings, baseline assessments of wound size and burn depth will be performed by the experienced physician and documented using photography and when indicated laser Doppler (Moor Laser Speckle®, Moor Instruments, Devon, UK) measurements. Time to heal will be defined as the time after which complete re-epithelialization is reached and PermeaDerm® detaches or there are no more changes of Mepilex Ag® needed. Secondary goals of the study are to assess pain, and scarring associated with the use of the different dressings in our burn patients, as well as to assess cost-effectiveness of the therapy. Pain will be assessed at every patient visit using visual analog scale (VAS) or Wong-Baker FACES respectively; mid and long-term scar development is assessed at approximately 1 and 6 months after enrollment in the study using Patient and Observer Scar Assessment Scale (POSAS) and DermaLab Combo® (Cortex Technology, Denmark).

Conditions

• Partial-thickness Burn

Interventions

Type	Name	Description
DEVICE	PermeaDerm	Wound treatment with PermeaDerm
DEVICE	Mepilex Ag	Wound treatment with Mepilex Ag

Timeline

• Start date: 2018-07-19
• Primary completion: 2018-12-01
• Completion: 2019-07-11
• First posted: 2018-08-03
• Last updated: 2023-06-18

Regulatory

• FDA-regulated device study