Burn Scar, Scar
Conditions
Keywords
stratagraft
Brief summary
The purpose of this study is to describe and better understand the scars of subjects that have been treated with Stratagraft tissue vs autograft.
Detailed description
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.
Interventions
OTHERPunch biopsy
punch biopsies will be used for histologic analysis and biochemical assays
OTHERnon-invasive photography, assessments, and measurements
photography, scar questionnaires, pain and itch assessments, and non-invasive measurements of scar including color, stiffness, and elasticity
Sponsors
Medstar Health Research Institute
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participant in STRATA2016 clinical trial 2. ≥ 18 years of age
Exclusion criteria
1. Unable to provide informed consent 2. Known allergy to lidocaine 3. Scars are not appropriate for investigation based on clinical judgement by the Principal Investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds | 1 DAY | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Qualitatively characterize scar resulting from Stratagraft-treated and autograft-treated wounds | 1 DAY | 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. |
Countries
United States
Outcome results
None listed