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

Active, not recruiting

• Conditions: Scar; Burn Scar
• Interventions: Other: Punch biopsy; Other: non-invasive photography, assessments, and measurements

• Registration Number: NCT04896346
• Lead Sponsor: Medstar Health Research Institute

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.

Study Timeline

• Study First Submitted: 2021-03-09
• Study First Submitted QC: 2021-05-20
• Study First Posted: 2021-05-21
• Study Start: 2022-02-09
• Primary Completion: 2022-10-03
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-28
• Last Update Posted: 2022-11-29
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Previous Treatment: Biologic StrataGraft Skin Tissue	Punch biopsy	This consists of areas that were treated with Stratagraft Skin Tissue under a previous clinical study STRATA2016. No new interventions will occur.
Previous Treatment: Biologic StrataGraft Skin Tissue	non-invasive photography, assessments, and measurements	This consists of areas that were treated with Stratagraft Skin Tissue under a previous clinical study STRATA2016. No new interventions will occur.
Previous Treatment: Autograft Comparator	Punch biopsy	This consists of areas that were treated with autograft comparator under a previous clinical study STRATA2016. No new interventions will occur.
Previous Treatment: Autograft Comparator	non-invasive photography, assessments, and measurements	This consists of areas that were treated with autograft comparator under a previous clinical study STRATA2016. No new interventions will occur.

Primary Outcome Measures

Name	Time	Method
Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds	1 DAY	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).

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

MedStar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States