Intraoperative CO₂ (Carbon Dioxide)

N/ANot Yet RecruitingNCT07592468

Baylor Research Institute50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Wound Edges

Interventions

CO2 Fractionated LaserDEVICE

intraoperative fractionated CO₂ laser treatment of surgical wound edges

Non CO2 Laser TreatmentPROCEDURE

Untreated CO2 fractionated laser wound edges

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

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

Locations (1)

Baylor University Medical Center

Dallas, Texas, United States

Outcomes

Primary Outcomes

Improvement of postoperative scar appearance

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

Secondary Outcomes

Scar Appearance

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

Physician Scar Assessments

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: 3 months

Clinical Safety and Healing Outcomes.

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.

Central Contacts

Umer Nadir, MD

CONTACT

214-820-2361 umer.nadir@bswhealth.org

Data from ClinicalTrials.gov

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