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

MedStar Health

Status: Active, not recruiting

Conditions: Scar; Burn Scar

Treatments: Other: non-invasive photography, assessments, and measurements; Other: Punch biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT04896346

STUDY00002861

Details and patient eligibility

About

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

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

5 participants in 2 patient groups

Previous Treatment: Biologic StrataGraft Skin Tissue

Description:

This consists of areas that were treated with Stratagraft Skin Tissue under a previous clinical study STRATA2016. No new interventions will occur.

Treatment:

Other: Punch biopsy

Other: non-invasive photography, assessments, and measurements

Previous Treatment: Autograft Comparator

Description:

This consists of areas that were treated with autograft comparator under a previous clinical study STRATA2016. No new interventions will occur.

Treatment:

Other: Punch biopsy

Other: non-invasive photography, assessments, and measurements