A Prospective Clinical Study Evaluating the Harvesting of Micografts

Chronic Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05076578
• Other study ID #: ARTIST-001
• Status: Completed
• Phase: N/A
• Start date: September 13, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: March 2022
• Source: SerenaGroup, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 1, 2022
• Est. primary completion date: November 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Wound

Intervention

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.

Locations

Country	Name	City	State
United States	SerenaGroup - Monroeville	Monroeville	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
SerenaGroup, Inc.	Medline Industries

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Mean time required for procedure.	Mean time required for procedure.	4 weeks
Other	Pain related to procedure (Group A and B).	Pain related to procedure (Group A and B) using a numeric scale 1-10.	4 weeks
Other	Assess therapeutic goals and benefit using Patient Benefit Index (PBI).	Assess therapeutic goals and benefit using Patient Benefit Index (PBI).	4 weeks
Other	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
Other	To assess biopsies using the ART device.	To collect biopsies from healthy volunteerrs from H&E plus Movat and Herovici staining.	4 weeks
Other	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
Other	Wear time of an occlusive dressing on donor site.	Wear time of an occlusive dressing on donor site.	4 weeks
Primary	To evaluate wound closure	Evaluating Wound Closure with Surface area through measurments	4 weeks
Primary	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
Primary	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	Proportion of patients that achieve complete wound closure	Proportion of patients that achieve complete wound closure by week 4. (Group B Only)	4 weeks
Secondary	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
Secondary	Difference in pain between baseline	Difference in pain between baseline and week 4 using a numeric scale 1-10. (Group B Only)	4 weeks
Secondary	Number of Treatments used per patient.	Number of Treatments used per patient. (Group B Only)	4 weeks
Secondary	• 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