NCT04896346

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 5 (actual)
• Sponsor: Medstar Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Burn Scar
• Scar

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-02-09
• Primary completion: 2022-10-03
• Completion: 2023-06-01
• First posted: 2021-05-21
• Last updated: 2022-11-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study