Comparison of Electrocautery and Scalpel for Upper Eyelid Blepharoplasty Incision: A Prospective Randomized Contralateral Comparative Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Skin excision time
Study Overview
Brief Summary
This prospective randomized contralateral comparative study aims to compare electrocautery and scalpel incision techniques in upper eyelid blepharoplasty. Each participant undergoes bilateral upper eyelid blepharoplasty, with one eyelid randomized to electrocautery incision and the contralateral eyelid to scalpel incision. Outcomes include postoperative pain, edema, ecchymosis, scar quality, wound healing, patient satisfaction, and surgeon satisfaction. The study is designed to determine whether electrocautery provides comparable or superior clinical outcomes while maintaining safety and surgical effectiveness.
Detailed Description
Upper eyelid blepharoplasty is one of the most commonly performed oculoplastic procedures. The skin incision can be made using either a conventional scalpel or electrocautery. Electrocautery may reduce intraoperative bleeding and improve visualization of the surgical field; however, concerns remain regarding thermal tissue injury, wound healing, scar formation, and postoperative outcomes.
This is a prospective, randomized, contralateral comparative clinical study. Adult patients undergoing bilateral upper eyelid blepharoplasty are enrolled. In each participant, one eyelid is randomly assigned to incision with electrocautery and the contralateral eyelid to incision with a scalpel, allowing each patient to serve as their own control and minimizing inter-individual variability.
Postoperative evaluations are performed at predefined follow-up visits. Primary and secondary outcome measures include postoperative pain, eyelid edema, ecchymosis, wound healing, scar quality, patient satisfaction, surgeon satisfaction, operative time, and procedure-related complications. Safety outcomes include the occurrence of adverse events such as infection, wound dehiscence, delayed healing, hematoma, or other surgery-related complications.
The objective of the study is to determine whether electrocautery incision is a safe and effective alternative to conventional scalpel incision for upper eyelid blepharoplasty.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Participants were masked to the intervention assigned to each eyelid. Postoperative outcomes were evaluated independently by two masked ophthalmic surgeons using standardized photographs. In case of disagreement, a third independent masked investigator determined the final score. The operating surgeon was not masked.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults aged 18 years or older.
- •Diagnosis of upper eyelid dermatochalasis.
- •Scheduled to undergo bilateral upper eyelid blepharoplasty.
- •Ability to provide written informed consent.
Exclusion Criteria
- •Previous eyelid surgery.
- •History of eyelid trauma.
- •Blepharochalasis syndrome.
- •Congenital eyelid anomalies.
- •Coagulation disorders.
- •Concurrent ptosis requiring surgical correction.
- •Inability or unwillingness to provide informed consent or comply with study follow-up.
Arms & Interventions
Scalpel incision
Upper eyelid blepharoplasty performed using scalpel skin incision.
Intervention: Scalpel incision (Procedure)
Electrocautery incision
Upper eyelid blepharoplasty performed using electrocautery incision.
Intervention: Electrocautery incision (Procedure)
Outcomes
Primary Outcomes
Skin excision time
Time Frame: During surgery (intraoperative)
Time required for skin incision and excision, measured separately for each eyelid from the initial skin incision to completion of planned skin excision using a digital stopwatch. Lower values indicate greater operative efficiency.
Intraoperative bleeding
Time Frame: During surgery (intraoperative)
Intraoperative bleeding was assessed separately for each eyelid by measuring the total number of cotton-tipped applicators used for hemostasis during skin incision and tissue dissection. A lower number indicated less intraoperative bleeding.
Postoperative ecchymosis
Time Frame: Postoperative day 1, week 1, month 1, month 3, and month 6
Postoperative ecchymosis was assessed from standardized photographs using ImageJ software. The ecchymotic area was measured in square centimeters and graded on a 5-point scale (0 = no ecchymosis; 1 = ≤2 cm²; 2 = \>2-4 cm²; 3 = \>4-6 cm²; 4 = \>6 cm²). Lower scores indicated less postoperative ecchymosis.
Postoperative edema
Time Frame: Postoperative day 1, week 1, month 1, month 3, and month 6
Postoperative eyelid edema was evaluated using a standardized 5-point grading scale (0 = none; 1 = minimal; 2 = edema extending to the iris; 3 = edema covering the iris; 4 = upper and lower eyelids swollen shut). Lower scores indicated less postoperative edema.
Scar visibility
Time Frame: Postoperative months 1, 3, and 6
Scar visibility was evaluated by masked observers using standardized postoperative photographs and graded on a 4-point ordinal scale (1 = invisible; 2 = mildly visible; 3 = moderately visible; 4 = highly visible). Lower scores indicated better scar appearance.
Hyperpigmentation and hypopigmentation
Time Frame: Postoperative months 1, 3, and 6
Postoperative hypopigmentation and hyperpigmentation were evaluated separately for each eyelid using standardized postoperative photographs and recorded as present or absent by masked observers.
Secondary Outcomes
- Corneal epithelial staining(Postoperative day 1, week 1, month 1, month 3, and month 6)
- Global Aesthetic Improvement Scale (GAIS)(Postoperative day 1, week 1, month 1, month 3, and month 6)
Investigators
Fatma Poslu Karademir
Ophthalmologist
Beyoglu Eye Research and Education Hospital