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
Verified date | March 2022 |
Source | SerenaGroup, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | SerenaGroup - Monroeville | Monroeville | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
SerenaGroup, Inc. | Medline Industries |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04887688 -
Exciflex for Chronic Wound Therapy
|
N/A | |
Terminated |
NCT03738579 -
Evaluating Wound Healing With Next Science Gel & Wash.
|
N/A | |
Enrolling by invitation |
NCT06444035 -
Extended Therapeutic Effect of 35kDa Hyaluronan Fragment Injection in Patients With Chronic Pain Caused by Myofascial Pain Syndrome
|
N/A | |
Completed |
NCT02417818 -
Cutaneous Microcirculation After Plasma Therapy
|
N/A | |
Completed |
NCT02417779 -
Cutaneous Microcirculation After Extracorporeal Shock Wave Therapy
|
N/A | |
Completed |
NCT02417805 -
Cutaneous Microcirculation After Remote Ischemic Preconditioning
|
N/A | |
Completed |
NCT03662997 -
Clinical Study to Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds
|
N/A | |
Not yet recruiting |
NCT04132635 -
A Trial to Evaluate the Combination Efficacy of Artificial Dermis and Growth Factor in Chronic Wounds Ulcer
|
N/A | |
Withdrawn |
NCT01646502 -
Treatment of Chronic Wound Biofilms
|
N/A | |
Recruiting |
NCT05342740 -
Study of Biomarkers in Diabetic Chronic Wounds
|
||
Suspended |
NCT02577120 -
Wound Healing Endpoint and Recurrence
|
Phase 4 | |
Recruiting |
NCT06185465 -
Effectiveness and Safety of Using Prontosan to Treat Bacterial Biofilm
|
N/A | |
Completed |
NCT04514783 -
Healthy Tissue Preservation During Wound Debridement by Using Debritom+ Micro Water Jet Technology
|
N/A | |
Terminated |
NCT01429519 -
Efficacy of RPh201 Applied Topically for the Treatment of Hard to Heal Chronic Ulcerated Wounds
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05974228 -
Bioglass Wound Dressing in Treatment of Chronic Wound in Different Stage:a Randomized Controlled Trial
|
N/A | |
Recruiting |
NCT05414916 -
Pain Relief Strategies for Dressing Change in Chronic Wounds
|
||
Recruiting |
NCT04019639 -
Efficacy of Paste Type Acellular Dermal Matrix(CG Paste) in Chronic Wound Healing
|
N/A | |
Completed |
NCT05810649 -
Local Injection for the Treatment of Chronic Wounds and Pain Caused by Chronic Wounds
|
N/A |