Scarring in Stratagraft-treated vs. Autograft-treated Burn Wounds: a Clinical and Histological Investigation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Scarring in Stratagraft-treated vs. Autograft-treated Burn Wounds: a Clinical and Histological Investigation

Conditions
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Burn Scar, Scar

Intervention / Treatment
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* Other: Punch biopsy
* Other: non-invasive photography, assessments, and measurements


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Participant in STRATA2016 clinical trial ≥ 18 years of age Exclusion Criteria Unable to provide informed consent Known allergy to lidocaine Scars are not appropriate for investigation based on clinical judgement by the Principal Investigator

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Previous Treatment: Biologic StrataGraft Skin Tissue<br>This consists of areas that were treated with Stratagraft Skin Tissue under a previous clinical study STRATA2016. No new interventions will occur. | Other: Punch biopsy<br>* punch biopsies will be used for histologic analysis and biochemical assays<br>Other: non-invasive photography, assessments, and measurements<br>* photography, scar questionnaires, pain and itch assessments, and non-invasive measurements of scar including color, stiffness, and elasticity<br>|
| Previous Treatment: Autograft Comparator<br>This consists of areas that were treated with autograft comparator under a previous clinical study STRATA2016. No new interventions will occur. | Other: Punch biopsy<br>* punch biopsies will be used for histologic analysis and biochemical assays<br>Other: non-invasive photography, assessments, and measurements<br>* photography, scar questionnaires, pain and itch assessments, and non-invasive measurements of scar including color, stiffness, and elasticity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 1 DAY | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 DAY | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stratagraft