Baylor University Medical Center
Dallas, Texas, 75246, United States
NCT Number: NCT07592468
To evaluate whether intraoperative fractionated CO₂ laser treatment of surgical wound edges improves postoperative scar appearance compared with untreated wound edges following Mohs micrographic surgery (MMS).
Trial opening soon.
Get Notified18 year–89 year
All sexes
Interventional
Not applicable
Dallas, Texas, 75246, United States
This is a randomized, split-scar clinical study. After patients undergo the MMS surgery and before the wound is closed one half of the wound edge will be treated with a CO2 laser and the other half will be untreated. The side of the would receiving the laser treatment will be determined by random assignment. The study aims to evaluate if the wound edge that is laser treated will have an improved scar appearance compared to the non-laser treated wound edge.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
intraoperative fractionated CO₂ laser treatment of surgical wound edges
Untreated CO2 fractionated laser wound edges
Time frame: 3 months
To evaluate whether intraoperative fractionated CO₂ laser treatment of surgical wound edges improves postoperative scar appearance compared with untreated wound edges following Mohs micrographic surgery. Evaluating the perspective of the scar from both the patient and medical professional using the Patient and Observer Scar Assessment Scale (POSAS), which evaluates scar quality. Using a scale of 1-10, where 1 is "like normal skin" and 10 is the "worst imaginable and using verbal feedback from patients about the appearance of their scars.
Time frame: 3 months
To assess patients overall satisfaction with scar appearance. This will be done verbally with patients stating they are "satisfied, somewhat satisfied, or not satisfied".
Time frame: 3 months
A group of blinded medical professionals will assess the treated and untreated scar using several standardized assessments. The first is the Patient and Observer Scar Assessment Scale (POSAS), which evaluates scar quality. Using a scale of 1-10, where 1 is "like normal skin" and 10 is the "worst imaginable. The second is the Vancouver Scar Scale (VSS). This scale evaluates scars across 4 physical characteristics using a score range of 0-13, where 0 represents normal skin and 13 represents the most severe scarring. Finally the third assessment is the Global Aesthetic Improvement Scale (GAIS). This scale looks at how much better the patient looks compared to pre-surgery. This scale uses a scoring range of 1-5, where 1 represents exceptional improvement and 5 represents worse.
Time frame: 1 week, 1 month, 3 months
To evaluate the safety of intraoperative fractionated CO₂ laser treatment, including healing time and complication rates. During the follow up visits the physician will do conduct a visual assessment for presence of any infection, dehiscence, poor wound healing. The physician will use a global assessment of 1-5 and the formal Patient and Observer Scar Assessment Scale (POSAS), which evaluates scar quality. Using a scale of 1-10, where 1 is "like normal skin" and 10 is the "worst imaginable.
Contact information is provided by the study sponsor or research team.
Baylor Research Institute
Other
Intraoperative Fractionated CO₂ Laser Treatment of Wound Edges During Mohs Micrographic Surgery
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