Wound Edges
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DEVICECO2 Fractionated Laser
intraoperative fractionated CO₂ laser treatment of surgical wound edges
PROCEDURENon CO2 Laser Treatment
Untreated CO2 fractionated laser wound edges
Sponsors
Baylor Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18-89 years * Diagnosis of cutaneous malignancy treated with MMS * Surgical defect suitable for primary linear or flap closure with adequate length to permit split-scar design * Ability to understand and provide informed consent
Exclusion criteria
* Pregnancy * Inability to provide informed consent * Non-English speaking patients * History of abnormal wound healing (e.g., keloid disorder) * Active infection at the surgical site * Immunosuppression felt to significantly impair wound healing * Use of isotretinoin within the past 6 months * Prior radiation therapy to the surgical site * Patients belonging to vulnerable populations including prisoners, children, or individuals unable to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of postoperative scar appearance | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Scar Appearance | 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". |
| Physician Scar Assessments | 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. |
| Clinical Safety and Healing Outcomes. | 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. |
Countries
United States
Contacts
CONTACTUmer Nadir, MD
PRINCIPAL_INVESTIGATORStan Tolkachjov, MD
Baylor Health Care System
Outcome results
None listed