RECELL to Promote Healing Following Carbon Dioxide (CO2) Laser Treatment in Cosmetic Patients

Study Overview
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Brief Summary
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To determine whether following Carbon dioxide (CO2) laser treatment, application of autologous cell suspension obtained via enzymatic and mechanical preparation will reduce negative side effects from CO2 laser and decrease the time of healing following treatment.

Detailed Description
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The perioral area of the face will be treated with CO2 laser. Laser setting will be determined by the treating surgeon for each individual patient. Typical settings to be used for severe facial photoaging is Energy (mj) 100-125, Scan Size 6-7 mm, Density 2-3, Hertz 100-200, Repeat Delay 0.3-1.5 seconds, number of passes 2. The patient would be randomized and blinded to either left perioral or right perioral RECELL application. The surgeon would also be blinded to which side received RECELL treatment or Placebo (saline spray). Randomization would occur before study initiation with subjects assigned either left perioral or right perioral RECELL treatment based on their subject enrollment number. The study team member who prepares and blinds the RECELL will create the list of subject ID numbers with subject ID number randomly assigned to either left perioral or right perioral treatment group. This will be completed prior to any patient enrollment in the study. This spreadsheet will be password protected and only accessible to study coordinators and the team member responsible for preparing RECELL.

Official Title
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Application of RECELL to Promote Healing Following CO2 Laser Treatment in Cosmetic Facelift Patients

Conditions
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Carbon Dioxide Laser, Photoaging

Intervention / Treatment
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* Drug: ReCell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 18 years or older Patients undergoing facelift with perioral CO2 laser treatment Skin that is Fitzpatrick Score 1 or 2 Exclusion Criteria: Prior perioral CO2 laser resurfacing Allergy to components of preparation system

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: The perioral area of the face will be treated with CO2 laser. Laser setting will be determined by the treating surgeon for each individual patient - . The patient would be randomized and blinded to either left perioral or right perioral RECELL application - The surgeon would also be blinded to which side received RECELL treatment or Placebo (saline spray)
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Right receives ReCell (A)<br>Right perioral area of face receives ReCell/ Left receives saline | Drug: ReCell<br>* The perioral area of the face will be treated with CO2 laser. Randomization would occur before study initiation with subjects assigned either left perioral or right perioral RECELL treatment based on their subject enrollment number. The study team member who prepares and blinds the RECELL will create the list of subject ID numbers with subject ID number randomly assigned to either left perioral or right perioral treatment group. This will be completed prior to any patient enrollment in the study. Intraoperatively, RECELL and Placebo will be provided to surgeons and assistants in opaque application devices prepared by a trained, designated study team member. Both the treatment and placebo sides, will be dressed with a standard autologous cell suspension post treatment dressing (Telfa Clear and Xeroform).<br>* Other names: autologous cell harvesting;|
| Other: Left receives ReCell (B)<br>Left perioral area of face receives ReCell/ Right receives saline | Drug: ReCell<br>* The perioral area of the face will be treated with CO2 laser. Randomization would occur before study initiation with subjects assigned either left perioral or right perioral RECELL treatment based on their subject enrollment number. The study team member who prepares and blinds the RECELL will create the list of subject ID numbers with subject ID number randomly assigned to either left perioral or right perioral treatment group. This will be completed prior to any patient enrollment in the study. Intraoperatively, RECELL and Placebo will be provided to surgeons and assistants in opaque application devices prepared by a trained, designated study team member. Both the treatment and placebo sides, will be dressed with a standard autologous cell suspension post treatment dressing (Telfa Clear and Xeroform).<br>* Other names: autologous cell harvesting;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Skin sensitivity scores - redness | surveys will be given to address redness - a scale of not at all, A little, moderately, or extremely | month 3 | 
| Change in Skin sensitivity scores - sensitivity to light | surveys will be given to address sensitivity to light - a scale of not at all, A little, moderately, or extremely | month 3 | 
| Change in Skin sensitivity scores - tightness | surveys will be given to address tightness - a scale of not at all, A little, moderately, or extremely | month 3 | 
| Change in Skin sensitivity scores - itching | surveys will be given to address itching - a scale of not at all, A little, moderately, or extremely | month 3 | 
| Change in Skin sensitivity scores - burning | surveys will be given to address burning - a scale of not at all, A little, moderately, or extremely | month 3 | 
| Change in FACE-Q scale scores | measure what participants think about their appearance, quality of life, adverse effects, and process of care - score from 0 to 100, with higher scores indicating a better outcome | Month 3 | 
| Change in Wong-Baker FACES Pain Assessment Tool scores | Wong-Baker FACES Pain Rating Scale - 1-10 pain scale - the higher the score the more pain | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing within 2 weeks post-op | Quantificare LifeViz Camera will be used - yes/no whether healing occurred within first 2 weeks post-op | month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laser, Facelift