Autologous Regeneration of Tissue (ART) for Wound Healing

Study Overview
=================
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.

Official Title
-----------------
Autologous Regeneration of Tissue (ART) for Wound Healing

Conditions
-----------------
Wound of Skin

Intervention / Treatment
-----------------
* Device: Autologous Regeneration of Tissue (ART) device


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>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<br>* This device will harvest hundreds of full-thickness columns of skin tissue (500 micrometer diameter) using single-needle, fluid-assisted harvesting technology.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of pain on harvesting of skin at donor site. | Pain assessed using a Pain Visual Analog Scale (VAS) with a score ranging from 0 (no pain) to 10 (worst possible pain) | Baseline, Day 56 | 
| Time to healing of donor sites | At each weekly visit, the donor site will be assessed for wound area in cm^2 | Up to Day 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing of recipient site | At each weekly visit, the recipient area will be assessed for healing area percentage | Up to Day 56 | 
| Histologic evaluation | As measured by tissue samples from biopsy | Up to Day 56 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Wound