ART Device for Skin Wound Healing

Recruiting in Palo Alto (17 mi)

Dr. Hadar Avihai Lev-Tov, MD - Miami ...

Overseen byHadar Lev-Tov, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Miami

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new device called ART that helps collect skin grafts from a patient's own skin. It is aimed at people who need skin grafts, such as those with burns or injuries. The device works by growing new skin from a small sample of the patient's own skin, which can then be used for healing.

Research Team

Hadar Lev-Tov, MD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for adults aged 18-90 with chronic wounds present for at least 30 days. Participants must be able to consent and cannot have leg lesions, significant arterial disease, need cancer treatment (except certain skin cancers), or be on immunosuppressants, radiation, cytotoxic agents. Pregnant women and those with conditions that may risk safety or study goals are excluded.

Inclusion Criteria

You have a wound that has been present for at least 30 days and has not healed.

Adults from 18 to 90 years of age

Able and willing to give consent for the study

Exclusion Criteria

You have leg wounds or serious blockages in your leg arteries that have not been treated.

You are currently receiving treatment for any type of cancer, except for certain types of skin cancer.

Subjects requiring concurrent systemic antimicrobials during the study period for any infection

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Treatment Details

Interventions

Autologous Regeneration of Tissue (ART) device (Tissue Regeneration)

Trial OverviewThe study is testing a new device called Autologous Regeneration of Tissue (ART) designed to collect skin grafts from the patient's own body to help heal chronic wounds.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Intervention armExperimental Treatment1 Intervention

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.