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Autologous Regeneration of Tissue (ART) for Wound Healing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03796988
Recruitment Status : Active, not recruiting
First Posted : January 8, 2019
Last Update Posted : December 27, 2021
Sponsor:
Collaborator:
Medline Industries
Information provided by (Responsible Party):
Hadar Lev-Tov, University of Miami

Study Description
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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.

Condition or disease Intervention/treatment Phase
Wound of Skin Device: Autologous Regeneration of Tissue (ART) device Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Regeneration of Tissue (ART) for Wound Healing
Actual Study Start Date : September 14, 2018
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change of pain on harvesting of skin at donor site. [ Time Frame: Baseline, Day 56 ]
    Pain assessed using a Pain Visual Analog Scale (VAS) with a score ranging from 0 (no pain) to 10 (worst possible pain)

  2. Time to healing of donor sites [ Time Frame: Up to Day 56 ]
    At each weekly visit, the donor site will be assessed for wound area in cm^2


Secondary Outcome Measures :
  1. Wound healing of recipient site [ Time Frame: Up to Day 56 ]
    At each weekly visit, the recipient area will be assessed for healing area percentage

  2. Histologic evaluation [ Time Frame: Up to Day 56 ]
    As measured by tissue samples from biopsy


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03796988


Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Medline Industries
Investigators
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Principal Investigator: Hadar Lev-Tov, MD University of Miami
More Information
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Responsible Party: Hadar Lev-Tov, Assistant Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03796988    
Other Study ID Numbers: 20180154
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: December 27, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Hadar Lev-Tov, University of Miami:
Chronic Wound
Additional relevant MeSH terms:
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Wounds and Injuries