A Prospective Clinical Study Evaluating the Harvesting of Micografts

A Prospective Clinical Study Evaluating the Efficiency of Full Thickness Micograft Harvesting in Healthy Volunteers and the Use of Full Thickness Micrografts in the Treatment of Patients With Chronic Wounds

ART (Autologous Regeneration of Tissue) is a revolutionary technology for harvesting skin without the drawbacks of conventional grafting. This innovative system allows the clinician to collect hundreds of microcolumns of full-thickness skin tissue and apply them directly to the wound site. It can all be done in an outpatient setting with minimized donor site concerns.

Study Overview

• Status: Completed
• Conditions: Chronic Wound
• Intervention / Treatment: Device: Autologous Regeneration of Tissue (ARTTM) system

Detailed Description

Millions of Americans suffer from acute and hard-to-heal chronic wounds. The National Institutes of Health estimates that 3% of the U.S. population over the age of 65 has an open wound. As the population ages in concert with an increased incidence of diabetes and obesity, the problem will intensify. A recent article suggests that the financial burden of wound care is approaching 100 billion dollars. Despite the gravity of the problem and the number of patients afflicted, open wounds can take weeks, months or even years to heal. The search for interventions that promote healing, reduce suffering and enhance quality of life continues as does the need to address the underlying issues that disrupt the wound healing process.

Countless hours are spent treating chronic wounds (diabetic ulcers, venous ulcers, pressure injuries). Called the "silent epidemic," chronic wounds often result in infection, disability and sometimes amputation.

Crafting a treatment plan that addresses the individual needs of each wound and each patient, hinges on managing the underlying issues that can disrupt healing and increase healthcare costs. Innovation in wound bed preparation and tissue regeneration bring new hope for these patients in the form of more effective wound closure, improved quality of life and reduced costs.

Autologous skin grafting is the gold standard for covering areas of skin loss.4 However, traditional grafting is limited by accessibility issues and donor site complications-pain, risk of infection, scarring.

ART (Autologous Regeneration of Tissue) is a revolutionary technology for harvesting skin without the drawbacks of conventional grafting. This innovative system allows the clinician to collect hundreds of microcolumns of full-thickness skin tissue and apply them directly to the wound site. It can all be done in an outpatient setting with minimized donor site concerns.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Monroeville, Pennsylvania, United States, 15146
      • SerenaGroup - Monroeville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Group A (Healthy Individuals)

1. 18 years or older.
2. Healthy participants without major diseases.

Group B (Subjects with Chronic Wounds)

1. Participants presenting with chronic wound(s) present for a minimum of 4 weeks (eg. diabetic foot ulcers (DFU), venous leg ulcers (VLU), pressure ulcers (PrU), and other acceptable etiologies).
2. 18 years or older.

Exclusion Criteria:

1. Subject on an investigational drug or therapeutic device within 30 days of the study visit.
2. Presence of a condition that PI considers will compromise the subject's ability to participate in the study.
3. Known allergy to any of the dressings or their components.
4. The subject has a history of excessive bleeding.
5. The subject has a history of keloid formation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Evaluate the harvesting of micografts in healthy and patients with chronic wounds; The ART Skin Harvesting System is intended to harvest full thickness skin microcolumns in a minimally invasive manner and scatter them at the recipient site. It consists of three components: (1) a non-sterile, reusable handheld device; (2) a sterile, single-patient use needle cartridge containing the needle array for harvesting skin micrografts from the patient donor site; and (3) a sterile, disposable handheld protective sleeve to cover the handheld device (figure 1). The sterile sleeve reduces contamination of the reusable handheld device and provides a sterile barrier between the non-sterile handheld device and the patient.

Device: Autologous Regeneration of Tissue (ARTTM) system; The ART Skin Harvesting System is intended to harvest full thickness skin microcolumns in a minimally invasive manner and scatter them at the recipient site. It consists of three components: (1) a non-sterile, reusable handheld device; (2) a sterile, single-patient use needle cartridge containing the needle array for harvesting skin micrografts from the patient donor site; and (3) a sterile, disposable handheld protective sleeve to cover the handheld device (figure 1). The sterile sleeve reduces contamination of the reusable handheld device and provides a sterile barrier between the non-sterile handheld device and the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate wound closure	Evaluating Wound Closure with Surface area through measurments	4 weeks
Group A (Healthy Volunteers): The number of successful full thickness micrograft harvests from calf, thigh, and lower back as a percentage of the maximal possible grafts.	Group A (Healthy Volunteers): The number of successful full thickness micrograft harvests from calf, thigh, and lower back as a percentage of the maximal possible grafts.	4 weeks
Group B (Chronic Wound patients): The number of wounds achieving a percentage area reduction (PAR) of 40% or greater in 4 weeks.	Group B (Chronic Wound patients): The number of wounds achieving a percentage area reduction (PAR) of 40% or greater in 4 weeks.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients that achieve complete wound closure	Proportion of patients that achieve complete wound closure by week 4. (Group B Only)	4 weeks
Time to initial wound closure within 4 weeks (Kaplan-Meier approach).	Time to initial wound closure within 4 weeks (Kaplan-Meier approach). (Group B only)	4 weeks
Difference in pain between baseline	Difference in pain between baseline and week 4 using a numeric scale 1-10. (Group B Only)	4 weeks
Number of Treatments used per patient.	Number of Treatments used per patient. (Group B Only)	4 weeks
• Incidence of adverse events (calculated as total and mean number per patient).	• Incidence of adverse events (calculated as total and mean number per patient). (Group B Only)	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of use for the Autologous Regeneration of Tissue (ART) system using System Usability Scale (SUS).	Ease of use for the ART system using System Usability Scale (SUS).Questionnaire with a series of questions. 1 being "Strongly disagree" and 5 being "strongly agree"	4 weeks
Mean time required for procedure.	Mean time required for procedure.	4 weeks
Pain related to procedure (Group A and B).	Pain related to procedure (Group A and B) using a numeric scale 1-10.	4 weeks
Assess therapeutic goals and benefit using Patient Benefit Index (PBI).	Assess therapeutic goals and benefit using Patient Benefit Index (PBI).	4 weeks
To assess samples through blood speciman	To collect histological samples from both healthy (Group A) and non-healing patients (Group B) for hematoxylin and eosin (H&E) processing and imaging using a microscope.	4 weeks
To assess biopsies using the ART device.	To collect biopsies from healthy volunteerrs from H&E plus Movat and Herovici staining.	4 weeks
Assessing the effect of bacterial burden on wound healing using the MolecuLight Imaging Device	The effect of bacterial burden on wound healing following micrograft placement using fluorescence imaging.	4 weeks
Wear time of an occlusive dressing on donor site.	Wear time of an occlusive dressing on donor site.	4 weeks

Collaborators and Investigators

• Sponsor: SerenaGroup, Inc.
• Collaborators: Medline Industries

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2021
• Primary Completion (Actual): November 22, 2021
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: October 1, 2021
• First Posted (Actual): October 13, 2021

Study Record Updates

• Last Update Posted (Actual): March 14, 2022
• Last Update Submitted That Met QC Criteria: March 11, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: ARTIST-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes