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

The purpose of this study is to describe and better understand the scars of subjects that have been treated with Stratagraft tissue vs autograft.

Study Overview

• Status: Active, not recruiting
• Conditions: Burn Scar; Scar
• Intervention / Treatment: Other: Punch biopsy; Other: non-invasive photography, assessments, and measurements

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.

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited using the participant enrollment records from the STRATA2016 that took place at MedStar Washington Hospital Center/MedStar Health Research Institute.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2022
• Primary Completion (Actual): October 3, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: March 9, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (Actual): May 21, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: stratagraft
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: STUDY00002861

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No