Clinical trial NCT05076578: A Prospective Clinical Study Evaluating the Harvesting of Micografts
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Wound
Lead sponsor: SerenaGroup, Inc.
Sponsor class: NETWORK
Collaborators: name: Medline Industries
First posted: 2021-10-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The ARTTM system is an electrically powered handheld device containing disposable sterile needle cartridges. The control elements include a push button that operates the back and forth movement of the needles in the cartridge. The device can harvest over 300 full thickness MicroColumns.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate wound closure
timeFrame: 4 weeks
measure: 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.
timeFrame: 4 weeks
measure: Group B (Chronic Wound patients): The number of wounds achieving a percentage area reduction (PAR) of 40% or greater in 4 weeks.
timeFrame: 4 weeks
Secondary outcomes:
measure: Proportion of patients that achieve complete wound closure
timeFrame: 4 weeks
measure: Time to initial wound closure within 4 weeks (Kaplan-Meier approach).
timeFrame: 4 weeks
measure: Difference in pain between baseline
timeFrame: 4 weeks
measure: Number of Treatments used per patient.
timeFrame: 4 weeks
measure: • Incidence of adverse events (calculated as total and mean number per patient).
timeFrame: 4 weeks
Other outcomes:
measure: Ease of use for the Autologous Regeneration of Tissue (ART) system using System Usability Scale (SUS).
timeFrame: 4 weeks
measure: Mean time required for procedure.
timeFrame: 4 weeks
measure: Pain related to procedure (Group A and B).
timeFrame: 4 weeks
measure: Assess therapeutic goals and benefit using Patient Benefit Index (PBI).
timeFrame: 4 weeks
measure: To assess samples through blood speciman
timeFrame: 4 weeks
measure: To assess biopsies using the ART device.
timeFrame: 4 weeks
measure: Assessing the effect of bacterial burden on wound healing using the MolecuLight Imaging Device
timeFrame: 4 weeks
measure: Wear time of an occlusive dressing on donor site.
timeFrame: 4 weeks
Locations:
city: Monroeville
country: United States
facility: SerenaGroup - Monroeville
state: Pennsylvania
Study officials:
affiliation: SerenaGroup, Inc.
name: Thomas Serena, MD,FACS
role: PRINCIPAL_INVESTIGATOR
References: