Wound of Skin
Conditions
Keywords
Chronic Wound
Brief summary
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.
Interventions
DEVICEAutologous 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.
Sponsors
Medline Industries
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Adults from 18 to 90 years of age. * Patients that have a chronic wound in any area of the body defined as having been present for at least 30 days of duration. * Able and willing to give consent for the study.
Exclusion criteria
* Pregnant women (Urine hCG test will be performed at baseline on women of child bearing potential). * Adults unable to consent. * Prisoners. * Subjects requiring concurrent systemic antimicrobials during the study period for any infection. * Subjects with leg lesions and clinically significant and unreconstructed peripheral arterial disease. * Subjects who are receiving immunosuppressive agents, radiation therapy, or cytotoxic agents. * Subjects who require treatment for a primary or metastatic malignancy (other than squamous or basal cell carcinoma of the skin). * Subjects with other conditions considered by the investigator to be reasons for disqualification that may jeopardize subject safety or interfere with the objectives of the trial (e.g., acute illness or exacerbation of chronic illness, lack of motivation, history of poor compliance).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Pain on Harvesting of Skin at Donor Site. | Baseline, Day 56 | Pain assessed using a Pain Visual Analog Scale (VAS) with a score ranging from 0 millimeters (no pain) to 100 millimeters (worst possible pain) |
| Time to Healing of Donor Sites | Up to Day 56 | At each weekly visit, the donor site will be assessed for healing based on clinical observation as measured by number of days from procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound Healing of Recipient Site | Up to Day 56 | At each weekly visit, the recipient area will be assessed for healing area percentage |
| Histologic Evaluation | Up to Day 56 | As measured by tissue samples from biopsy |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | Intervention Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 22 |
| other Total, other adverse events | 11 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
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)
Time frame: Baseline, Day 56
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Change of Pain on Harvesting of Skin at Donor Site. | 2.6 millimeters | Standard Deviation 5.9 |
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.
Time frame: Up to Day 56
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Time to Healing of Donor Sites | 24 Days | Standard Deviation 17 |
Secondary
Histologic Evaluation
As measured by tissue samples from biopsy
Time frame: Up to Day 56
Population: 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.
Secondary
Wound Healing of Recipient Site
At each weekly visit, the recipient area will be assessed for healing area percentage
Time frame: Up to Day 56
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Wound Healing of Recipient Site | -3.6 percentage of wound area healing | Standard Deviation 16.7 |