Clinical trial NCT03613870: PermeaDerm® vs. Mepilex-Ag® in Promoting Healing of Partial-thickness Burn Wounds
Official title: A Prospective, Randomized, Parallel Study to Evaluate the Effectiveness of PermeaDerm® and Mepilex-Ag® in Promoting Healing of Partial-thickness Burn Wounds
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Partial-thickness Burn
Keywords: PermeaDerm, Mepilex Ag, partial thickness burn wounds
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: 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

Primary outcomes:
measure: Time to heal
timeFrame: up to 3 weeks after injury
Secondary outcomes:
measure: Pain assessment using Visual Analog Pain Scale (VAS) or Wong-Baker FACES pain rating scales (age dependent)
timeFrame: Changes over first 30 days post injury, using regression modeling for analysis.
measure: Scar assessment with Patient and Observer Assessment Scale (POSAS)
timeFrame: at 1 month post injury
measure: Scar assessment with Patient and Observer Assessment Scale (POSAS)
timeFrame: at 6 months post injury
measure: Scarring with DermaLab Combo device: Viscoelasticity
timeFrame: at 1 month post injury
measure: Scarring with DermaLab Combo device: Viscoelasticity
timeFrame: at 6 months post injury
measure: Scarring with DermaLab Combo device: Hydration
timeFrame: at 1 month post injury
measure: Scarring with DermaLab Combo device: Hydration
timeFrame: at 6 months post injury
measure: Scarring with DermaLab Combo device: Pigmentation
timeFrame: at 1 month post injury
measure: Scarring with DermaLab Combo device: Pigmentation
timeFrame: at 6 months post injury
measure: Scarring with DermaLab Combo device: Trans epithermal water loss
timeFrame: at 1 month post injury
measure: Scarring with DermaLab Combo device: Trans epithermal water loss
timeFrame: at 6 months post injury
measure: Rate of Infection
timeFrame: at 1 month post burn
measure: Cost-effectiveness
timeFrame: at 1 month post burn
Other outcomes:
Locations:
Study officials:
affiliation: The University of Texas Medical Branch, Galveston
name: Ludwik K Branski, MD
role: PRINCIPAL_INVESTIGATOR
References: