Autologous Regeneration of Tissue (ART) for Wound Healing

NCT ID: NCT03796988

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-14
• Study Completion Date: 2024-03-19

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.

Conditions

Wound of Skin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Autologous Regeneration of Tissue (ART) device

Intervention Type: DEVICE

This device will harvest hundreds of full-thickness columns of skin tissue (500 micrometer diameter) using single-needle, fluid-assisted harvesting technology.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medline Industries

INDUSTRY

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Hadar Lev-Tov

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hadar Lev-Tov, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

20180154

Identifier Type: -

Identifier Source: org_study_id