Intraoperative CO₂ (Carbon Dioxide)

Intraoperative Fractionated CO₂ Laser Treatment of Wound Edges During Mohs Micrographic Surgery

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Wound Edges
• Intervention / Treatment: Device: CO2 Fractionated Laser; Procedure: Non CO2 Laser Treatment

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Umer Nadir, MD; Phone Number: 214-820-2361; Email: umer.nadir@bswhealth.org

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CO2 Laser Treated Edge	Device: CO2 Fractionated Laser; intraoperative fractionated CO₂ laser treatment of surgical wound edges
Active Comparator: Non-laser treated edge	Procedure: Non CO2 Laser Treatment; Untreated CO2 fractionated laser wound edges

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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".	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.	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.	1 week, 1 month, 3 months

Collaborators and Investigators

• Sponsor: Baylor Research Institute
• Investigators: Principal Investigator: Stan Tolkachjov, MD, Baylor Health Care System

Publications and helpful links

General Publications

• Ji Q, Luo L, Ni J, Pu X, Qiu H, Wu D. Fractional CO2 Laser to Treat Surgical Scars: A System Review and Meta-Analysis on Optimal Timing. J Cosmet Dermatol. 2025 Jan;24(1):e16708. doi: 10.1111/jocd.16708.
• Ozog DM, Moy RL. A randomized split-scar study of intraoperative treatment of surgical wound edges to minimize scarring. Arch Dermatol. 2011 Sep;147(9):1108-10. doi: 10.1001/archdermatol.2011.248. No abstract available.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: May 11, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 026-177

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No