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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1
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).
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Change in Skin Sensitivity Scores - Redness
surveys will be given to address redness - a scale of "not at all, A little, moderately, or extremely" Scale is, "not at all", "a little", "moderately", "extremely"
Time frame: 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" Score is, "not at all", "a little", "moderately", "extremely"
Time frame: 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"
Time frame: 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"
Time frame: 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"
Time frame: 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
Time frame: Month 3
Healing Within 2 Weeks Post-op
Quantificare LifeViz Camera will be used - yes/no whether healing occurred within first 2 weeks post-op
Time frame: month 3
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