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| Name | Class |
|---|---|
| Medline Industries | INDUSTRY |
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The purpose of this research study is to learn about a new device, Autologous Regeneration of Tissue (ART), for collecting skin grafts from participant's own skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | The donor area will be anesthetized with injected local anesthesia, harvested with the ART device, and bandaged with an occlusive dressing. The skin harvested will be placed on the recipient wound area. The area will be bandaged will a non-stick silicone dressing (covered by appropriate primary and secondary dressings) and left intact for 1-7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Regeneration of Tissue (ART) device | Device | This device will harvest hundreds of full-thickness columns of skin tissue (500 micrometer diameter) using single-needle, fluid-assisted harvesting technology. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Pain on Harvesting of Skin at Donor Site. | Pain assessed using a Pain Visual Analog Scale (VAS) with a score ranging from 0 millimeters (no pain) to 100 millimeters (worst possible pain) | Baseline, Day 56 |
| Time to Healing of Donor Sites | At each weekly visit, the donor site will be assessed for healing based on clinical observation as measured by number of days from procedure. | Up to Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Healing of Recipient Site | At each weekly visit, the recipient area will be assessed for healing area percentage | Up to Day 56 |
| Histologic Evaluation | As measured by tissue samples from biopsy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hadar Lev-Tov, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Arm | The donor area will be anesthetized with injected local anesthesia, harvested with the ART device, and bandaged with an occlusive dressing. The skin harvested will be placed on the recipient wound area. The area will be bandaged will a non-stick silicone dressing (covered by appropriate primary and secondary dressings) and left intact for 1-7 days. Autologous Regeneration of Tissue (ART) device: This device will harvest hundreds of full-thickness columns of skin tissue (500 micrometer diameter) using single-needle, fluid-assisted harvesting technology. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Arm | The donor area will be anesthetized with injected local anesthesia, harvested with the ART device, and bandaged with an occlusive dressing. The skin harvested will be placed on the recipient wound area. The area will be bandaged will a non-stick silicone dressing (covered by appropriate primary and secondary dressings) and left intact for 1-7 days. Autologous Regeneration of Tissue (ART) device: This device will harvest hundreds of full-thickness columns of skin tissue (500 micrometer diameter) using single-needle, fluid-assisted harvesting technology. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change of Pain on Harvesting of Skin at Donor Site. | Pain assessed using a Pain Visual Analog Scale (VAS) with a score ranging from 0 millimeters (no pain) to 100 millimeters (worst possible pain) | Posted | Mean | Standard Deviation | millimeters | Baseline, Day 56 |
|
8 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Arm | The donor area will be anesthetized with injected local anesthesia, harvested with the ART device, and bandaged with an occlusive dressing. The skin harvested will be placed on the recipient wound area. The area will be bandaged will a non-stick silicone dressing (covered by appropriate primary and secondary dressings) and left intact for 1-7 days. Autologous Regeneration of Tissue (ART) device: This device will harvest hundreds of full-thickness columns of skin tissue (500 micrometer diameter) using single-needle, fluid-assisted harvesting technology. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bruising | Injury, poisoning and procedural complications | Systematic Assessment | A grade 1 localized at the donor site. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hadar Lev-Tov, Assistant Professor | University of Miami | 305-243-4472 | hltevtov@med.miami.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 11, 2021 | Apr 3, 2025 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D027724 | Reproductive Techniques, Assisted |
| ID | Term |
|---|---|
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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| Up to Day 56 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Time to Healing of Donor Sites | At each weekly visit, the donor site will be assessed for healing based on clinical observation as measured by number of days from procedure. | Posted | Mean | Standard Deviation | Days | Up to Day 56 |
|
|
|
| Secondary | Wound Healing of Recipient Site | At each weekly visit, the recipient area will be assessed for healing area percentage | Posted | Mean | Standard Deviation | percentage of wound area healing | Up to Day 56 |
|
|
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| Secondary | Histologic Evaluation | As measured by tissue samples from biopsy | This was an optional biopsy of the donor site at the final visit (approximately day 56). All participants opted to not participate in this optional procedure. Therefore, no data was collected. | Posted | Up to Day 56 |
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 11 |
| 22 |
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| Skin Infection | Infections and infestations | Systematic Assessment | Participants that experienced a target wound Cellulitis. |
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| Skin Infections | Infections and infestations | Systematic Assessment | Participants that experienced cellulitis at the donor site. |
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| Skin Infections | Infections and infestations | Systematic Assessment | Participants that experienced contact dermatitis at the target wound. |
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| Respiratory Infection | Infections and infestations | Systematic Assessment | Participants that experienced COVID-19 symptoms. |
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