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

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).

Inclusion Criteria:

- Superficial partial thickness burn injury due to flame burn, scald injury or contact
burn that does not require excision and grafting

- Total Body Surface Area burned (TBSA) total ≤30 %

- Admission within 72 hours of burn injury

- Non-infected wound as diagnosed by the attending physician upon admission

- Treated as an outpatient or in an observational setting

Exclusion Criteria:

- Patient younger than 6 months

- Causes other than contact burn, flame or scald injuries (i.e., electrical, chemical or
frostbite)

- Admission time greater than 72 hours after the injury

- Wounds noted to be infected at admission

- Previous treatment efforts such as previous debridement, silver sulfadiazine ointment
or other pseudo eschar-forming topical agents

- Pregnancy/lactation