Intraoperative CO₂ (Carbon Dioxide)

NCT07592468 | Not Yet Recruiting FDA Device

• 1 other identifier: 026-177
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Wound Edges

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Scar Appearance

  3 months

• Physician Scar Assessments

  3 months

• Clinical Safety and Healing Outcomes.

  1 week, 1 month, 3 months

Study Arms (2)

CO2 Laser Treated Edge

ACTIVE COMPARATOR

Device: CO2 Fractionated Laser

Non-laser treated edge

ACTIVE COMPARATOR

Procedure: Non CO2 Laser Treatment

Interventions

CO2 Fractionated Laser DEVICE

intraoperative fractionated CO₂ laser treatment of surgical wound edges

CO2 Laser Treated Edge

Non CO2 Laser Treatment PROCEDURE

Untreated CO2 fractionated laser wound edges

Non-laser treated edge

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Related Publications (2)

• 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.

  PMID: 39780524 BACKGROUND

• 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.

  PMID: 21931055 BACKGROUND

Study Officials

• Stan Tolkachjov, MD

  Baylor Health Care System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Umer Nadir, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 18, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)