Wound of SkinNCT05324514
Microscopic Skin Tissue Column Grafting Technique Using the Autologous Regeneration of Tissue System
A study testing Split-thickness skin grafting, High density microscopic skin tissue column grafting and Low density microscopic skin tissue column grafting in people with Wound of Skin and Burns, run by The Metis Foundation.
Trial summary
This study evaluates Microscopic Skin Tissue Column (MSTC) grafting technique using the Autologous Regeneration Tissue (ART) System in the treatment of skin loss. Each participant will have three study treated areas, the three treatments include: 1. traditional grafting, 2. high density MSTC, 3. low density MSTC. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Wound of Skin, Burns
- What is being tested?
- Split-thickness skin grafting, High density microscopic skin tissue column grafting and Low density microscopic skin tissue column grafting
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to Dec 2024
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 and age less than or equal to 70.
- Skin loss from surgery, trauma, and/or burns.
- Presence of one uniform contiguous wound ≥150cm2
- Sufficient non-injured healthy skin from which conventional STSG can be harvested to cover study and non-study sites.
- Sufficient non-injured healthy skin from which the study device can be used to harvest MSTC to cover the study sites.
- Study donor site has not been previously harvested.
- Able and likely to follow-up, to have three consecutive appointments and appear for 6 month follow up visit.
- Subject agrees to abstain from enrollment in any other interventional clinical trial while enrolled in this study.
Who cannot join
- Exposure of tendon, bone devoid of peritenon or periosteum, or other structures deemed non-graftable by the treating physician or study investigator.
- Concomitant skin disease/infection at the recipient or donor sites.
- Use of topical steroid, anti-metabolite, or other pharmacologic therapy on study site.
- Use of systemic steroids in the past month.
- Concurrent conditions that in the opinion of the investigator may compromise subject safety, study objectives or wound healing.
- Current recipient of immunosuppressive therapy.
Show all 11Show fewer
- Current treatment with medication that inhibit/compromise wound healing.
- Known history of malignancy.
- Pregnancy or lactation
- Prisoner
- History of noncompliance ->40% total body surface area involvement.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Full-Thickness Microscopic Skin Tissue Column Grafting Technique Using the ART (Autologous Regeneration Tissue) System: An Interventional Clinical Trial
This study evaluates Microscopic Skin Tissue Column (MSTC) grafting technique using the Autologous Regeneration Tissue (ART) System in the treatment of skin loss. Each participant will have three study treated areas, the three treatments include: 1. traditional grafting, 2. high density MSTC, 3. low density MSTC.
Read the detailed description
The current standard of care for coverage of large open wounds is split-thickness skin graft (STSG). These STSGs are typically harvested with a dermatome, which tangentially removes the epidermis and a thin layer of dermis from a healthy donor site. While relatively versatile, there are important limitations to STSGs. First, a healthy and readily accessible donor site is required prior to grafting. Second, each donor site itself becomes an open wound and is unable for grafting for approximately two weeks as the wound heals. To facilitate wound coverage, harvested STSG can be meshed up to a rate of 6:1 (though more common ratios are 1:1 and 2:1). However, widely meshed grafts tend to produce more severe scars and contractures, which represent tremendous long-term morbidity to the patient.
The only means to avoid using widely meshed grafts is to harvest additional healthy donor skin, resulting in more pain from larger wound burdens and disfiguring scars in previously uninjured regions. Finally, STSG does not include deeper dermal structures such as hair follicles and sweat glands, and as such these grafts are both functionally and aesthetically substandard. Recently, skin microcolumn grafting has been proposed to address both skin graft donor site morbidity and long-term graft contracture. Specifically, the Autologous Regeneration of Tissue (ART)TM System, an FDA-cleared device, harvests full-thickness microscopic skin tissue columns (MSTC) orthogonally instead of tangentially; each skin column includes epidermis, dermis and associated adnexal structures, and subcutaneous fat. These MSTC cover an area up to 10x larger than the donor site (100:1 ratio, compared to up to 6:1 using STSG). Inclusion of adnexal structures results in improved wound-healing quality, less scarring, and a lower rate of secondary contracture. The small wounds caused by the ART system at the donor site during MSTC harvesting heal quickly and without the comorbidities associated with traditional harvesting. This autologous approach maintains low immunogenicity as no foreign or synthetic tissue is used as a skin substitute, which decreases the chance of infection or rejection in the wound bed. In short, the ART system allows for expansion of a donor site to a ratio of 1:100, faster healing of the donor site while still preserving donor site function, and improved healing of the original wound.
The investigators will conduct a prospective, randomized controlled clinical trial comparing the MSTC grafting technique to the standard of care. Treatment sites will be randomized to either receiving MSTC or the traditional STSG. Objective measurements and assessments will be completed during subject follow-ups visits for up to six months.
- Conditions
- Wound of Skin, Burns
- Being tested
- Split-thickness skin grafting, High density microscopic skin tissue column grafting, Low density microscopic skin tissue column grafting
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Split-thickness skin graftingProcedure or surgery
Harvesting for split-thickness skin grafting will be performed at the specified donor site using a pneumatically powered dermatome with a setting of 10 /1000th inch and meshed 2:1.
High density microscopic skin tissue column graftingDevice
MSTC harvest will be conducted using the ART system (Medline Industries) in accordance with the manufacturer's instructions and distributed at high density (300-360 columns/50cm2).
Low density microscopic skin tissue column graftingDevice
MSTC harvest will be conducted using the ART system (Medline Industries) in accordance with the manufacturer's instructions and distributed at low density (150-180 columns/50cm2).
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | STSG grafting application. Receives: Procedure: Split-thickness skin grafting |
| High Density | Experimental | MSTC high density application. Receives: Device: High density microscopic skin tissue column grafting |
| Low Density | Experimental | MSTC low density application. Receives: Device: Low density microscopic skin tissue column grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of healing
The rate of healing of the donor sites will be assessed utilizing clinical assessments and photography with 3D camera and the Silhouette Star wound camera.
Measured: Day 7
Rate of epithelialization
The rate of epithelialization will be assessed utilizing clinical assessments and photography with 3D camera and the Silhouette Star wound camera.
Measured: Day 7
Rate of healing
The rate of healing of the donor sites will be assessed utilizing clinical assessments and photography with 3D camera and the Silhouette Star wound camera.
Measured: Day 14
Rate of epithelialization
The rate of epithelialization will be assessed utilizing clinical assessments and photography with 3D camera and the Silhouette Star wound camera.
Measured: Day 14
Secondary outcomes (9)
Incidence of pain
Donor sites will be assessed for incidence and level of pain experienced.
Measured: Day 3- Month 6
Skin function
Skin function as measures by the validated Patient and Observer Scar Assessment Scale. The Patient and Observer Scar Assessment scale uses a 0-10 scale 0 being normal appearance, 10 being the worst possible outcome (POSAS).
Measured: Day 17- Month 6
Presence of adnexal structures
Presence of adnexal structures will be assessed by obtaining a wound biopsy.
Measured: Day 30, Month 6
Reepithelization
Clinical assessment for the need to re-graft treatment sites.
Measured: Day 3- month 6
Skin appearence
Skin appearance measured using Vancouver Scar Scale (VSS). VSS rates Vascularity, pigmentation, pliability, and hight of the affected skin using a numeric scale to get an overall total of 1-13.
Measured: Day 17- Month 6
Skin pliability
Skin pliability measured using a Dermal torque meter (DTM).
Measured: Day 17- Month 6
Skin integrity
Skin integrity measured by a tewameter. The tewameter is a measuring device for the assessment of the trans-epidermal water loss (TEWL).
Measured: Day 17- Month 6
Skin pressure
Skin pressure measured using a semmes-weinstein aesthesiometer
Measured: Day 17- Month 6
Skin color
Skin color to be measured using colorimeter.
Measured: Day 17- Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start1 Oct 2022 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound of SkinStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will have three wound sites that will be randomized to receive either the standard of care treatment, high density microscopic tissue skin columns, or low density microscopic tissue skin columns.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Metis Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324514
- Sponsor's protocol ID
- ART-1
- Status last verified
- Aug 2022
- First submitted
- 3 Oct 2019
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Full-Thickness Microscopic Skin Tissue Column Grafting Technique Using the ART (Autologous Regeneration Tissue) System: An Interventional Clinical Trial
- ClinicalTrials.gov ID
- NCT05324514
- Acronym / sponsor ID
- ART-1
- Conditions
- Wound of Skin, Burns
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Metis FoundationUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Apr 2022 (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.
This study evaluates Microscopic Skin Tissue Column (MSTC) grafting technique using the Autologous Regeneration Tissue (ART) System in the treatment of skin loss. Each participant will have three study treated areas, the three treatments include: 1. traditional grafting, 2. high density MSTC, 3. low density MSTC.
Detailed description
The current standard of care for coverage of large open wounds is split-thickness skin graft (STSG). These STSGs are typically harvested with a dermatome, which tangentially removes the epidermis and a thin layer of dermis from a healthy donor site. While relatively versatile, there are important limitations to STSGs. First, a healthy and readily accessible donor site is required prior to grafting. Second, each donor site itself becomes an open wound and is unable for grafting for approximately two weeks as the wound heals. To facilitate wound coverage, harvested STSG can be meshed up to a rate of 6:1 (though more common ratios are 1:1 and 2:1). However, widely meshed grafts tend to produce more severe scars and contractures, which represent tremendous long-term morbidity to the patient.
The only means to avoid using widely meshed grafts is to harvest additional healthy donor skin, resulting in more pain from larger wound burdens and disfiguring scars in previously uninjured regions. Finally, STSG does not include deeper dermal structures such as hair follicles and sweat glands, and as such these grafts are both functionally and aesthetically substandard. Recently, skin microcolumn grafting has been proposed to address both skin graft donor site morbidity and long-term graft contracture. Specifically, the Autologous Regeneration of Tissue (ART)TM System, an FDA-cleared device, harvests full-thickness microscopic skin tissue columns (MSTC) orthogonally instead of tangentially; each skin column includes epidermis, dermis and associated adnexal structures, and subcutaneous fat. These MSTC cover an area up to 10x larger than the donor site (100:1 ratio, compared to up to 6:1 using STSG). Inclusion of adnexal structures results in improved wound-healing quality, less scarring, and a lower rate of secondary contracture. The small wounds caused by the ART system at the donor site during MSTC harvesting heal quickly and without the comorbidities associated with traditional harvesting. This autologous approach maintains low immunogenicity as no foreign or synthetic tissue is used as a skin substitute, which decreases the chance of infection or rejection in the wound bed. In short, the ART system allows for expansion of a donor site to a ratio of 1:100, faster healing of the donor site while still preserving donor site function, and improved healing of the original wound.
The investigators will conduct a prospective, randomized controlled clinical trial comparing the MSTC grafting technique to the standard of care. Treatment sites will be randomized to either receiving MSTC or the traditional STSG. Objective measurements and assessments will be completed during subject follow-ups visits for up to six months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will have three wound sites that will be randomized to receive either the standard of care treatment, high density microscopic tissue skin columns, or low density microscopic tissue skin columns.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Procedure: Split-thickness skin graftingSTSG grafting application. |
| High Density | Experimental | Device: High density microscopic skin tissue column graftingMSTC high density application. |
| Low Density | Experimental | Device: Low density microscopic skin tissue column graftingMSTC low density application. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age greater than or equal to 18 and age less than or equal to 70.
- Skin loss from surgery, trauma, and/or burns.
- Presence of one uniform contiguous wound ≥150cm2
- Sufficient non-injured healthy skin from which conventional STSG can be harvested to cover study and non-study sites.
- Sufficient non-injured healthy skin from which the study device can be used to harvest MSTC to cover the study sites.
Key exclusion criteria (11 listed)
- Exposure of tendon, bone devoid of peritenon or periosteum, or other structures deemed non-graftable by the treating physician or study investigator.
- Concomitant skin disease/infection at the recipient or donor sites.
- Use of topical steroid, anti-metabolite, or other pharmacologic therapy on study site.
- Use of systemic steroids in the past month.
- Concurrent conditions that in the opinion of the investigator may compromise subject safety, study objectives or wound healing.
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 |
|---|---|---|
| Split-thickness skin graftingHarvesting for split-thickness skin grafting will be performed at the specified donor site using a pneumatically powered dermatome with a setting of 10 /1000th inch and meshed 2:1. | Procedure or surgery | Standard of Care |
| High density microscopic skin tissue column graftingMSTC harvest will be conducted using the ART system (Medline Industries) in accordance with the manufacturer's instructions and distributed at high density (300-360 columns/50cm2). | Device | High Density |
| Low density microscopic skin tissue column graftingMSTC harvest will be conducted using the ART system (Medline Industries) in accordance with the manufacturer's instructions and distributed at low density (150-180 columns/50cm2). | Device | Low Density |
Primary outcome
Rate of healing
Time frame: Day 7
The rate of healing of the donor sites will be assessed utilizing clinical assessments and photography with 3D camera and the Silhouette Star wound camera.
Rate of epithelialization
Time frame: Day 7
The rate of epithelialization will be assessed utilizing clinical assessments and photography with 3D camera and the Silhouette Star wound camera.
Rate of healing
Time frame: Day 14
The rate of healing of the donor sites will be assessed utilizing clinical assessments and photography with 3D camera and the Silhouette Star wound camera.
Rate of epithelialization
Time frame: Day 14
The rate of epithelialization will be assessed utilizing clinical assessments and photography with 3D camera and the Silhouette Star wound camera.
9 secondary outcomes
Incidence of pain
Time frame: Day 3- Month 6
Skin function
Time frame: Day 17- Month 6
Presence of adnexal structures
Time frame: Day 30, Month 6
Reepithelization
Time frame: Day 3- month 6
Skin appearence
Time frame: Day 17- Month 6
Skin pliability
Time frame: Day 17- Month 6
Skin integrity
Time frame: Day 17- Month 6
Skin pressure
Time frame: Day 17- Month 6
Skin color
Time frame: Day 17- Month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Split-thickness skin grafting, High density microscopic skin tissue column grafting and Low density microscopic skin tissue column grafting in people with Wound of Skin and Burns, run by The Metis Foundation.
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 8 inclusion and 11 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 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Victoria Diaz, RN (210-569-1140, diaz@metisfoundationusa.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of healing (time frame: Day 7). The study lists 4 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 25 Aug 2022.