Autologous Regeneration of Tissue (ART) for Wound Healing

Not Applicable

Active, not recruiting

• Conditions: Wound of Skin
• Interventions: Device: Autologous Regeneration of Tissue (ART) device

• Registration Number: NCT03796988
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-09-14
• Study First Submitted: 2019-01-03
• Study First Submitted QC: 2019-01-07
• Study First Posted: 2019-01-08
• Status Verified: 2024-06
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention arm	Autologous Regeneration of Tissue (ART) device	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.

Primary Outcome Measures

Name	Time	Method
Change of pain on harvesting of skin at donor site.	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)
Time to healing of donor sites	Up to Day 56	At each weekly visit, the donor site will be assessed for wound area in cm\^2

Secondary Outcome Measures

Name	Time	Method
Histologic evaluation	Up to Day 56	As measured by tissue samples from biopsy
Wound healing of recipient site	Up to Day 56	At each weekly visit, the recipient area will be assessed for healing area percentage

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States