Trial Outcomes & Findings for Autologous Regeneration of Tissue (ART) for Wound Healing (NCT NCT03796988)

Last Updated: 2025-04-23

Results Overview

Pain assessed using a Pain Visual Analog Scale (VAS) with a score ranging from 0 millimeters (no pain) to 100 millimeters (worst possible pain)

Recruitment status

COMPLETED

Study phase

Target enrollment

22 participants

Primary outcome timeframe

Baseline, Day 56

Results posted on

2025-04-23

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	22
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Autologous Regeneration of Tissue (ART) for Wound Healing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Arm n=22 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Intervention Arm n=22 Participants 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.
Change of Pain on Harvesting of Skin at Donor Site.	2.6 millimeters Standard Deviation 5.9

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention Arm n=22 Participants 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.
Time to Healing of Donor Sites	24 Days Standard Deviation 17

SECONDARY outcome

Timeframe: Up to Day 56

At each weekly visit, the recipient area will be assessed for healing area percentage

Outcome measures

Outcome measures
Measure	Intervention Arm n=22 Participants 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.
Wound Healing of Recipient Site	-3.6 percentage of wound area healing Standard Deviation 16.7

SECONDARY outcome

Timeframe: 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.

As measured by tissue samples from biopsy

Outcome measures

Outcome data not reported

Adverse Events

Intervention Arm

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intervention Arm n=22 participants at risk 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.
Injury, poisoning and procedural complications Bruising	45.5% 10/22 • Number of events 10 • 8 weeks.
Infections and infestations Skin Infection	9.1% 2/22 • Number of events 2 • 8 weeks.
Infections and infestations Skin Infections	4.5% 1/22 • Number of events 1 • 8 weeks.
Infections and infestations Respiratory Infection	4.5% 1/22 • Number of events 1 • 8 weeks.

Additional Information

Hadar Lev-Tov, Assistant Professor

University of Miami

Phone: 305-243-4472

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place