Purpose

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)

Condition

Eligibility

Eligible Ages
Between 6 Months and 99 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
PermeaDerm
Participants receive PermeaDerm dressing for wound treatment until wounds have healed completely
  • Device: PermeaDerm
    Wound treatment with PermeaDerm
Active Comparator
Mepilex Ag
Participants receive Mepilex Ag dressing for wound treatment until wounds have healed completely
  • Device: Mepilex Ag
    Wound treatment with Mepilex Ag

Recruiting Locations

University of texas Medical Branch Galveston
Galveston, Texas 77555
Contact:
Daniel Popp, MD
409-770-6600
danielpopp@utmb.edu

More Details

NCT ID
NCT03613870
Status
Recruiting
Sponsor
The University of Texas Medical Branch, Galveston

Study Contact

Daniel Popp, MD
409-770-6600
danpopp@utmb.edu

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.