The purpose of this study is to describe and better understand the scars of subjects that have been treated with Stratagraft tissue vs autograft.
This study will recruit patients who have previously been participants in the STRATA2016 study protocol. The patients will have comprehensive scar examinations conducted including the use of imaging, scar scale scores, pain and itch scales, scar volume measurements, and non-invasive skin measurements resulting in quantitative metrics of skin elasticity, stiffness, and color. Tissue biopsies will also be collected for histologic investigations into the scar. Each patient will have a biopsy taken of the autografted site, the Stratagraft site, and an area of normal, un-injured skin.
Study Type
OBSERVATIONAL
Enrollment
5
punch biopsies will be used for histologic analysis and biochemical assays
photography, scar questionnaires, pain and itch assessments, and non-invasive measurements of scar including color, stiffness, and elasticity
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds
Vancouver Scar Scale scores will be compared between scars originating from Stratagraft-treated burn wounds vs. autograft-treated burn wounds. The data will be normalized to uninjured skin. Min value for this scale is 0 and maximum value is 13. The higher the score, the worse the scar/outcome.
Time frame: 1 DAY
Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds
Patient and Observer Scar Assessment Scale (POSAS) scores will be compared between scars originating from Stratagraft-treated burn wounds vs. autograft-treated burn wounds. The data will be normalized to uninjured skin. Min value for this scale for the patient and observer components are 14 and maximum value is 140. The higher the score, the worse the scar/outcome.
Time frame: 1 DAY
Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds
Pain visual analogue scale scores will be compared between scars originating from Stratagraft-treated burn wounds vs. autograft-treated burn wounds. The data will be normalized to uninjured skin. The lowest value for this scale is 0 and the highest is 100. The higher the value to worse the outcome of pain.
Time frame: 1 DAY
Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds
Itch visual analogue scale scores will be compared between scars originating from Stratagraft-treated burn wounds vs. autograft-treated burn wounds. The data will be normalized to uninjured skin. The lowest value for this scale is 0 and the highest is 100. The higher the value to worse the outcome of itch.
Time frame: 1 DAY
Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds
Non-invasive skin probe measuring color will be compared between scars originating from Stratagraft-treated burn wounds vs. autograft-treated burn wounds. The data will be normalized to uninjured skin.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 1 DAY
Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds
Non-invasive skin probe measuring elasticity will be compared between scars originating from Stratagraft-treated burn wounds vs. autograft-treated burn wounds. The data will be normalized to uninjured skin.
Time frame: 1 DAY
Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds
Non-invasive skin probe measuring stiffness will be compared between scars originating from Stratagraft-treated burn wounds vs. autograft-treated burn wounds. The data will be normalized to uninjured skin.
Time frame: 1 DAY
Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds
Histologic measurements will be compared between scars originating from Stratagraft-treated burn wounds vs. autograft-treated burn wounds. The data will be normalized to uninjured skin. The specific parameters being measured include epidermal thickness (microns), dermal thickness (microns), scar cellularity (percentages), and rete ridge ratios (ratio of basement membrane length over epidermis length).
Time frame: 1 DAY
Qualitatively characterize scar resulting from Stratagraft-treated and autograft-treated wounds
Digital images and 3D photography will be used to qualitatively characterize scars. Formalin-fixed, paraffin embedded (FFPE) samples will be used to generate sections which will be stained with Massons trichrome (overall collagen), Pircosirius red (type I and III collagen), Verhoeff Van Geison (elastin), and Fontana Masson (melanin) stains. These stained sections will be imaged and used to qualitatively characterize scar resulting from Stratagraft-treated burn wounds and SOC-treated burn wounds. Images will be normalized to uninjured skin.
Time frame: 1 DAY