Comparison of Incision Site Scarring in Upper Eyelid Blepharoplasty Using CO2 Laser Versus Cold Steel Scalpel: A Non-Randomized Pilot Clinical Trial Study

Comparison of Incision Site Scarring in Upper Eyelid Blepharoplasty Using CO2 Laser Versus Cold Steel Scalpel: A Non-Randomized Pilot Clinical Trial Study

Preliminary clinical trial (Pilot), non-randomized, with parallel groups, on 20 patients. Patients will be assigned to two groups, "Scalpel" (control group) and "CO2 laser" (intervention group) based on personal preference.

A pilot, quasi-experimental study at Imam Khomeini Hospital (Dermatology Clinic), Ahvaz. Participants are divided into CO2 laser and scalpel groups. Surgery follows standard protocols using the Edge ONE device. Blinding: Blinded outcome assessment: The outcome assessor will be unaware of the treatment group (CO2 laser vs. scalpel) to minimize bias.

Inclusion criteria: Adults aged 30–60 years eligible for upper eyelid blepharoplasty with no contraindicating ocular conditions. Exclusion criteria: Refusal to participate, coagulation disorders or anticoagulant use, previous eyelid surgery or trauma, active eyelid disease or infection, immunodeficiency, HIV, hepatitis B/C, diabetic neuropathy, or history of keloid formation.

Intervention group: Upper eyelid blepharoplasty using a CO₂ laser (Edge One, Jeisys, South Korea) under local anesthesia (2% lidocaine with epinephrine 1:100,000), with wound closure using 6-0 nylon sutures. Control group: Upper eyelid blepharoplasty using a No. 15 surgical scalpel under local anesthesia (2% lidocaine with epinephrine 1:100,000), with wound closure using 6-0 nylon sutures.

Manchester Scar Scale score

Because of the nature of the surgical intervention, blinding of the surgeon and participants is not feasible. Therefore, the study is designed as a single-blind clinical trial. To implement blinding, standardized photographs will be obtained from all participants before surgery and at the 60-day follow-up under identical conditions (camera angle, distance, lighting, and patient position). All photographs will be coded with unique identification numbers, and no information regarding the intervention (CO₂ laser or cold steel scalpel) will be available to the outcome assessors. Scar quality will be evaluated using the Manchester Scar Scale by three independent assessors who are not involved in the surgical procedures or patient allocation and are fully blinded to the intervention received. In addition, the statistical analyst will receive a coded dataset (e.g., Group A and Group B) without access to treatment allocation, and statistical analyses will be performed while remaining blinded to the intervention groups.