Burn ScarNCT04896346
Scarring in Stratagraft-treated vs. Autograft-treated Burn Wounds: a Clinical and Histological Investigation
An observational study of Burn Scar and Scar, run by Medstar Health Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Punch biopsy and non-invasive photography, assessments, and measurements
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2022to Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Participant in STRATA2016 clinical trial
- ≥ 18 years of age
Who cannot join
- Unable to provide informed consent
- Known allergy to lidocaine
- Scars are not appropriate for investigation based on clinical judgement by the Principal Investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
The purpose of this study is to describe and better understand the scars of subjects that have been treated with Stratagraft tissue vs autograft.
Read the 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.
- Being tested
- Punch biopsy, non-invasive photography, assessments, and measurements
- Keywords
- stratagraft
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Punch biopsyOther
punch biopsies will be used for histologic analysis and biochemical assays
non-invasive photography, assessments, and measurementsOther
photography, scar questionnaires, pain and itch assessments, and non-invasive measurements of scar including color, stiffness, and elasticity
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Punch biopsy; Other: non-invasive photography, assessments, and measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 1 DAY
Secondary outcomes (1)
Qualitatively characterize scar resulting from Stratagraft-treated and autograft-treated wounds
Digital images and 3D photography will be used to qualitatively characterize scars.
Formalin-fixed, paraffin embedded (FFPE) samples will be used to generate sections which will be stained with Massons trichrome (overall collagen), Pircosirius red (type I and III collagen), Verhoeff Van Geison (elastin), and Fontana Masson (melanin) stains. These stained sections will be imaged and used to qualitatively characterize scar resulting from Stratagraft-treated burn wounds and SOC-treated burn wounds. Images will be normalized to uninjured skin.
Measured: 1 DAY
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start9 Feb 2022
- Primary completion3 Oct 2022
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896346
- Sponsor's protocol ID
- STUDY00002861
- Status last verified
- Nov 2022
- First submitted
- 9 Mar 2021
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scarring in Stratagraft-treated vs. Autograft-treated Burn Wounds: a Clinical and Histological Investigation
- ClinicalTrials.gov ID
- NCT04896346
- Acronym / sponsor ID
- STUDY00002861
- Keywords
- stratagraft
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 3 Oct 2022 (actual)
- Study completion
- Jun 2023 (estimated)
- First posted
- 21 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Previous Treatment: Biologic StrataGraft Skin Tissue | – | Other: Punch biopsy, Other: non-invasive photography, assessments, and measurementsThis consists of areas that were treated with Stratagraft Skin Tissue under a previous clinical study STRATA2016. No new interventions will occur. |
| Previous Treatment: Autograft Comparator | – | Other: Punch biopsy, Other: non-invasive photography, assessments, and measurementsThis consists of areas that were treated with autograft comparator under a previous clinical study STRATA2016. No new interventions will occur. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Participant in STRATA2016 clinical trial
- ≥ 18 years of age
Key exclusion criteria (3 listed)
- Unable to provide informed consent
- Known allergy to lidocaine
- Scars are not appropriate for investigation based on clinical judgement by the Principal Investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Punch biopsypunch biopsies will be used for histologic analysis and biochemical assays | Other | Previous Treatment: Autograft Comparator, Previous Treatment: Biologic StrataGraft Skin Tissue |
| non-invasive photography, assessments, and measurementsphotography, scar questionnaires, pain and itch assessments, and non-invasive measurements of scar including color, stiffness, and elasticity | Other | Previous Treatment: Autograft Comparator, Previous Treatment: Biologic StrataGraft Skin Tissue |
Primary outcome
Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds
Time frame: 1 DAY
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.
Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds
Time frame: 1 DAY
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.
Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds
Time frame: 1 DAY
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.
Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds
Time frame: 1 DAY
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.
Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds
Time frame: 1 DAY
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.
Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds
Time frame: 1 DAY
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.
Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds
Time frame: 1 DAY
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.
Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds
Time frame: 1 DAY
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 secondary outcome
Qualitatively characterize scar resulting from Stratagraft-treated and autograft-treated wounds
Time frame: 1 DAY
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
Related trials for Burn Scar
Not yet recruitingObservational study
Recurrence of Extremity Joint Contracture After Z-Plasty Versus Full-Thickness Skin Graft
Joint Contracture, Contracture
RecruitingPhase 3
Novel Strategies for Reducing Burn Scar Itch
Burn Scar, Itch Scarring
RecruitingPhase 2/3
Post-Operative Use of FS2 to Mitigate Scarring in Burn Patients
Burn Scar, Burn Wound
Not yet recruiting
Tools for Return of Facial Function
Facial Scarring, Facial Trauma
Not yet recruiting
Carbon Dioxide Laser-Assisted Delivery of Triamcinolone With or Without 5-Fluorouracil for Hypertrophic Burn Scars
Burn, Hypertrophic Scars
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burn Scar and Scar, run by Medstar Health Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize post-burn scar resulting from Stratagraft-treated and autograft-treated wounds (time frame: 1 DAY). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022; AzTrials last refreshed its copy on 7 Nov 2026.