Wound EdgesNCT07592468
Intraoperative CO₂ (Carbon Dioxide)
A study testing CO2 Fractionated Laser and Non CO2 Laser Treatment in people with Wound Edges, run by Baylor Research Institute at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Wound Edges
- What is being tested?
- CO2 Fractionated Laser and Non CO2 Laser Treatment
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Baylor University Medical Center
Dallas, Texas, 75246
About this study
Official title: 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).
Read the 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.
- Conditions
- Wound Edges
- Being tested
- CO2 Fractionated Laser, Non CO2 Laser Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 Fractionated LaserDevice
intraoperative fractionated CO₂ laser treatment of surgical wound edges
Non CO2 Laser TreatmentProcedure or surgery
Untreated CO2 fractionated laser wound edges
| Study group | Role | What they receive |
|---|---|---|
| CO2 Laser Treated Edge | Active comparator | Not described Receives: Device: CO2 Fractionated Laser |
| Non-laser treated edge | Active comparator | Not described Receives: Procedure: Non CO2 Laser Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (3)
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".
Measured: 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.
Measured: 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.
Measured: 1 week, 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Wound EdgesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stan Tolkachjov, MD, Principal investigator, Baylor Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592468
- Sponsor's protocol ID
- 026-177
- Status last verified
- Oct 2026
- First submitted
- 5 May 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 39780524Ozog 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.
PubMed 21931055
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Fractionated CO₂ Laser Treatment of Wound Edges During Mohs Micrographic Surgery
- ClinicalTrials.gov ID
- NCT07592468
- Acronym / sponsor ID
- 026-177
- Conditions
- Wound Edges
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CO2 Laser Treated Edge | Active comparator | Device: CO2 Fractionated Laser |
| Non-laser treated edge | Active comparator | Procedure: Non CO2 Laser Treatment |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO2 Fractionated Laserintraoperative fractionated CO₂ laser treatment of surgical wound edges | Device | CO2 Laser Treated Edge |
| Non CO2 Laser TreatmentUntreated CO2 fractionated laser wound edges | Procedure or surgery | Non-laser treated edge |
Primary outcome
Improvement of postoperative scar appearance
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.
3 secondary outcomes
Scar Appearance
Time frame: 3 months
Physician Scar Assessments
Time frame: 3 months
Clinical Safety and Healing Outcomes.
Time frame: 1 week, 1 month, 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 39780524Ji 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.
- Background: PubMed 21931055Ozog 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stan Tolkachjov, MD principal investigator
Baylor Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO2 Fractionated Laser and Non CO2 Laser Treatment in people with Wound Edges, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Umer Nadir, MD (214-820-2361, umer.nadir@bswhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of postoperative scar appearance (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07592468, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.