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

Scar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04896346
• Other study ID #: STUDY00002861
• Status: Active, not recruiting
• Start date: February 9, 2022
• Est. completion date: June 2023

Study information

• Verified date: November 2022
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: June 2023
• Est. primary completion date: October 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burn Scar
• Burns
• Scar

Intervention

Other:
• Punch biopsy
punch biopsies will be used for histologic analysis and biochemical assays
• non-invasive photography, assessments, and measurements
photography, scar questionnaires, pain and itch assessments, and non-invasive measurements of scar including color, stiffness, and elasticity

Locations

Country	Name	City	State
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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