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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Partial-thickness Burn

Intervention / Treatment
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* Device: PermeaDerm
* Device: Mepilex Ag


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PermeaDerm<br>Participants receive PermeaDerm dressing for wound treatment until wounds have healed completely | Device: PermeaDerm<br>* Wound treatment with PermeaDerm<br>|
| Active Comparator: Mepilex Ag<br>Participants receive Mepilex Ag dressing for wound treatment until wounds have healed completely | Device: Mepilex Ag<br>* Wound treatment with Mepilex Ag<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to heal | Time until wound is complete healed in days. A wound is considered as completely healed, when either PermeaDerm detaches on its own or no more dressings need to be applied in the Mepilex group. This time point is defined when approximately 95% of the wound shows epithelialization as determined by an experienced burn surgeon. | up to 3 weeks after injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment using Visual Analog Pain Scale (VAS) or Wong-Baker FACES pain rating scales (age dependent) | Pain assessment using Visual Analog Scale rating Pain scores ranging from 0-10 (8 years and older) OR Wong-Baker FACES Pain Rating Scale (3-7 years old). FACES stands for faces, since this rating scale shows faces from very happy to very unhappy. It ranges also from 0-10. Higher values indicating greater pain. The 0-10 scores for each scale are equivalent. | Changes over first 30 days post injury, using regression modeling for analysis. | 
| Scar assessment with Patient and Observer Assessment Scale (POSAS) | Using Patient and Observer Scar Assessment Scale POSAS, what is a composite score that is rating the overall appearance of the scar, based on each single score for rating vascularity, pigmentation, thickness, relief, pliability, surface. Every subscore ranges from 1-10. The composite score is calculated as an average of the subscores. Higher numbers mean worse scarring. | at 1 month post injury | 
| Scar assessment with Patient and Observer Assessment Scale (POSAS) | Using Patient and Observer Scar Assessment Scale POSAS, what is a composite score that is rating the overall appearance of the scar, based on each single score for rating vascularity, pigmentation, thickness, relief, pliability, surface. Every subscore ranges from 1-10. The composite score is calculated as an average of the subscores. Higher numbers mean worse scarring. | at 6 months post injury | 
| Scarring with DermaLab Combo device: Viscoelasticity | Measured through negative suction and retraction time. | at 1 month post injury | 
| Scarring with DermaLab Combo device: Viscoelasticity | Measured through negative suction and retraction time. | at 6 months post injury | 
| Scarring with DermaLab Combo device: Hydration | Measured based on skin conductance. | at 1 month post injury | 
| Scarring with DermaLab Combo device: Hydration | Measured based on skin conductance. | at 6 months post injury | 
| Scarring with DermaLab Combo device: Pigmentation | Measured based on light absorption of melanin and erythema | at 1 month post injury | 
| Scarring with DermaLab Combo device: Pigmentation | Measured based on light absorption of melanin and erythema | at 6 months post injury | 
| Scarring with DermaLab Combo device: Trans epithermal water loss | Measuring evaporation in g/meter square/hour | at 1 month post injury | 
| Scarring with DermaLab Combo device: Trans epithermal water loss | Measuring evaporation in g/meter square/hour | at 6 months post injury | 
| Rate of Infection | Defined as bacterial growth of >10 to power of 5 in swab. Only taken when infection suspected. | at 1 month post burn | 
| Cost-effectiveness | Number of dressing changes required until healing versus respective product costs (costs per cm square) | at 1 month post burn | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PermeaDerm, Mepilex Ag, partial thickness burn wounds