Clinical trial NCT04896346: Scarring in Stratagraft-treated vs. Autograft-treated Burn Wounds: a Clinical and Histological Investigation
Official title: Scarring in Stratagraft-treated vs. Autograft-treated Burn Wounds: a Clinical and Histological Investigation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Burn Scar
Scar
Keywords: stratagraft
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds
timeFrame: 1 DAY
measure: Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds
timeFrame: 1 DAY
measure: Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds
timeFrame: 1 DAY
measure: Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds
timeFrame: 1 DAY
measure: Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds
timeFrame: 1 DAY
measure: Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds
timeFrame: 1 DAY
measure: Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds
timeFrame: 1 DAY
measure: Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds
timeFrame: 1 DAY
Secondary outcomes:
measure: Qualitatively characterize scar resulting from Stratagraft-treated and autograft-treated wounds
timeFrame: 1 DAY
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
Study officials:
References: