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

NCT04896346 | Unknown FDA Drug

• 1 other identifier: STUDY00002861
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Burn Scar; Scar

Keywords

stratagraft

Outcome Measures

Primary Outcomes (8)

• Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds

  Vancouver Scar Scale scores will be compared between scars originating from Stratagraft-treated burn wounds vs. autograft-treated burn wounds. The data will be normalized to uninjured skin. Min value for this scale is 0 and maximum value is 13. The higher the score, the worse the scar/outcome.

  1 DAY

• Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds

  Patient and Observer Scar Assessment Scale (POSAS) scores will be compared between scars originating from Stratagraft-treated burn wounds vs. autograft-treated burn wounds. The data will be normalized to uninjured skin. Min value for this scale for the patient and observer components are 14 and maximum value is 140. The higher the score, the worse the scar/outcome.

  1 DAY

• Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds

  Pain visual analogue scale scores 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 lowest value for this scale is 0 and the highest is 100. The higher the value to worse the outcome of pain.

  1 DAY

• Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds

  Itch visual analogue scale scores 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 lowest value for this scale is 0 and the highest is 100. The higher the value to worse the outcome of itch.

  1 DAY

• Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds

  Non-invasive skin probe measuring color will be compared between scars originating from Stratagraft-treated burn wounds vs. autograft-treated burn wounds. The data will be normalized to uninjured skin.

  1 DAY

• Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds

  Non-invasive skin probe measuring elasticity will be compared between scars originating from Stratagraft-treated burn wounds vs. autograft-treated burn wounds. The data will be normalized to uninjured skin.

  1 DAY

• Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds

  Non-invasive skin probe measuring stiffness will be compared between scars originating from Stratagraft-treated burn wounds vs. autograft-treated burn wounds. The data will be normalized to uninjured skin.

  1 DAY

• Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds

  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).

  1 DAY

Secondary Outcomes (1)

• Qualitatively characterize scar resulting from Stratagraft-treated and autograft-treated wounds

  1 DAY

Study Arms (2)

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.

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

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.

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

Interventions

Punch biopsy OTHER

punch biopsies will be used for histologic analysis and biochemical assays

Previous Treatment: Autograft Comparator; Previous Treatment: Biologic StrataGraft Skin Tissue

non-invasive photography, assessments, and measurements OTHER

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

Previous Treatment: Autograft Comparator; Previous Treatment: Biologic StrataGraft Skin Tissue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Participant in STRATA2016 clinical trial
• ≥ 18 years of age

You may not qualify if:

• Unable to provide informed consent
• Known allergy to lidocaine
• Scars are not appropriate for investigation based on clinical judgement by the Principal Investigator

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

One 3-millimeter punch biopsy will be obtained from each subjects Stratagraft Treated Site, Autograft Comparator Site, and Normal Skin. Blood will be collected using EDTA, SST, PAXgene RNA and PAXgene DNA tubes for future analysis.

MeSH Terms

Conditions

Cicatrix

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: May 21, 2021
• Study Start: February 9, 2022
• Primary Completion: October 3, 2022
• Study Completion: June 1, 2023
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

US (1)