Healing Study of Fractional Skin Resurfacing and Tissue Histopathology After Ellacor Treatment
NCT Number: NCT06502470
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Wrinkle|Rhytides|Histopathology
Interventions: DEVICE: ellacor® Micro-Coring procedure
Sponsor: Cytrellis Biosystems, Inc.
Collaborators: Dallas Plastic Surgery Institute
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 3
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-04-30
Completion Date: 2024-05-17
Locations: Dallas Plastic Surgery Institute, Dallas, Texas, 75231, United States

Summary:
The goal of this study is to observe the healing of skin after ellacor® treatment at different timepoints, depths and coring densities. The visual comparison of treated areas to untreated control areas will improve understanding of how the ellacor® procedure works to induce skin resurfacing using an abdominoplasty, or tummy tuck surgery, model. The people participating in the study will have already decided that they want to have an abdominoplasty procedure.

The main questions this study aims to answer are:

How does human skin change after a series of the ellacor® procedures over a 14-day period?

Is the ellacor® device safe to use at different treatment time points, depths and densities?

The ellacor® procedure will be performed on people who are going to have abdominoplasty surgery. The ellacor® treatment areas will be limited to the skin areas marked for removal during the abdominoplasty. The treated tissue will be sent to a lab for microscopic study after the abdominoplasty procedure is complete. A minimum of 3 people will be treated in the study.

The 3 participants will have the ellacor® procedure done at 4 different timepoints before their abdominoplasty surgery: -14 days, -7 days, -3 days and on day 0, just prior to the abdominoplasty procedure. At each treatment timepoint the participants will have 3 areas treated using a depth of 7mm and different skin removal percent settings of 5%, 7% and 8%. The participants will have photos taken of the treatment areas and will be asked about any changes to their health or medications over the 14-day study.

Researchers will study the abdominoplasty tissue under a microscope after it has been removed from the participants. They will compare the areas treated by the ellacor® device to an area left untreated, which is the control area. This will reveal, by visual comparison, any changes in the skin tissue between treated and untreated areas, if they occur.

Primary Outcome Measures: Incidence and severity of adverse events, The incidence and severity of adverse events will be evaluated for all subjects enrolled to the study., Adverse events will be collected from Day 0 (the initial ellacor treatment day) through the day of the scheduled abdominoplasty procedure (Day 14 for all subjects).|The change in histopathology of abdominoplasty tissue samples after sequential treatments with the ellacor® device at a micro-coring depth of 7mm over a 14-day period as compared to an untreated control area., This 14-day healing evaluation of fractional skin resurfacing will compare the histopathology of stained tissue isolated after sequential ellacor® treatments on abdominal skin tissue. The samples will be isolated from excised abdominal tissue following abdominoplasty. The tissue will include an untreated control area compared to three ellacor® treated areas with depth of treatment at 7mm and different tissue percentage removal settings. Area 1 = 5% tissue removal, Area 2 = 7% and Area 3 = 8%. Each area will be treated on Day -14, Day -7, Day -3 and Day 0, the day of abdominoplasty. Histopathological evaluation will include Hematoxylin and Eosin (H\&E), Herovici, and Movat stains. The stains will provide comparison of structural tissue changes (H\&E stain), change in presence of Type III (young) collagen and Type I (mature) collagen (Herovici stain) and change in presence of collagen, fibrin and elastic fibers (Movat stain) over the 14-day time period compared to untreated control area., The abdominoplasty tissue will be excised 14 days after the initial ellacor® treatment. Histopathological studies will be performed upon receipt at the central pathology laboratory.