Health TrialsbyHealthPanel

Intraoperative CO₂ (Carbon Dioxide)

ConditionWound Edges
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorBaylor Research Institute

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnancy

Inability to provide informed consent

Non-English speaking patients

History of abnormal wound healing (e.g., keloid disorder)

Trial design

Design model

Parallel

Treatments tested in this trial

  • CO2 Fractionated Laser

    Device

    intraoperative fractionated CO₂ laser treatment of surgical wound edges

  • Non CO2 Laser Treatment

    Procedure/Surgery

    Untreated CO2 fractionated laser wound edges

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: CO2 Laser Treated EdgeActive comparator 1 intervention
Group B: Non-laser treated edgeActive comparator 1 intervention

Trial outcomes

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.

Time frame
3 months

Secondary outcomes

1

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
2

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
3

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.

Time frame
1 week, 1 month, 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baylor Research Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: