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

NCT ID: NCT04896346

Last Updated: 2022-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-09

Study Completion Date

2023-06-30

Brief Summary

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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

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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

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Burn Scar Scar

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Previous Treatment: Biologic StrataGraft Skin Tissue

This consists of areas that were treated with Stratagraft Skin Tissue under a previous clinical study STRATA2016.

No new interventions will occur.

Punch biopsy

Intervention Type OTHER

punch biopsies will be used for histologic analysis and biochemical assays

non-invasive photography, assessments, and measurements

Intervention Type OTHER

photography, scar questionnaires, pain and itch assessments, and non-invasive measurements of scar including color, stiffness, and elasticity

Previous Treatment: Autograft Comparator

This consists of areas that were treated with autograft comparator under a previous clinical study STRATA2016.

No new interventions will occur.

Punch biopsy

Intervention Type OTHER

punch biopsies will be used for histologic analysis and biochemical assays

non-invasive photography, assessments, and measurements

Intervention Type OTHER

photography, scar questionnaires, pain and itch assessments, and non-invasive measurements of scar including color, stiffness, and elasticity

Interventions

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Punch biopsy

punch biopsies will be used for histologic analysis and biochemical assays

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medstar Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00002861

Identifier Type: -

Identifier Source: org_study_id

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