Autologous Regeneration of Tissue (ART) for Wound Healing

University of Miami

Status: Completed

Conditions: Wound of Skin

Treatments: Device: Autologous Regeneration of Tissue (ART) device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03796988

20180154

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Intervention arm

Experimental group

Description:

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.

Treatment:

Device: Autologous Regeneration of Tissue (ART) device