An interventional study of PermeaDerm and Mepilex Ag in Partial-thickness Burn, sponsored by The University of Texas Medical Branch, Galveston. Withdrawn. Open to participants aged 6 Months to 99 Years. Per ClinicalTrials.gov, last updated 2023-06-18.
Sponsored by The University of Texas Medical Branch, Galveston · Not applicable, Interventional, and Treatment
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)
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).
719 studies on the registry are indexed under Burns; 145 are open to participants now.
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Exclusion Criteria:
Participants receive PermeaDerm dressing for wound treatment until wounds have healed completely
Device: PermeaDerm
Participants receive Mepilex Ag dressing for wound treatment until wounds have healed completely
Device: Mepilex Ag
Wound treatment with PermeaDerm
Wound treatment with Mepilex Ag
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.
Time frame: up to 3 weeks after injury
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.
Time frame: 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.
Time frame: 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.
Time frame: at 6 months post injury
Scarring with DermaLab Combo device: Viscoelasticity
Measured through negative suction and retraction time.
Time frame: at 1 month post injury
Scarring with DermaLab Combo device: Viscoelasticity
Measured through negative suction and retraction time.
Time frame: at 6 months post injury
Scarring with DermaLab Combo device: Hydration
Measured based on skin conductance.
Time frame: at 1 month post injury
Scarring with DermaLab Combo device: Hydration
Measured based on skin conductance.
Time frame: at 6 months post injury
Scarring with DermaLab Combo device: Pigmentation
Measured based on light absorption of melanin and erythema
Time frame: at 1 month post injury
Scarring with DermaLab Combo device: Pigmentation
Measured based on light absorption of melanin and erythema
Time frame: at 6 months post injury
Scarring with DermaLab Combo device: Trans epithermal water loss
Measuring evaporation in g/meter square/hour
Time frame: at 1 month post injury
Scarring with DermaLab Combo device: Trans epithermal water loss
Measuring evaporation in g/meter square/hour
Time frame: 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.
Time frame: at 1 month post burn
Cost-effectiveness
Number of dressing changes required until healing versus respective product costs (costs per cm square)
Time frame: at 1 month post burn
No study locations are listed for this record.
Plan to share: No — data won't be shared
No publications or documents are linked to this record.
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The University of Texas Medical Branch, Galveston