Comparison of Electrocautery and Scalpel for Upper Eyelid Blepharoplasty Incision: A Prospective Randomized Contralateral Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Skin excision time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •Diagnosis of upper eyelid dermatochalasis.
- •Scheduled to undergo bilateral upper eyelid blepharoplasty.
- •Ability to provide written informed consent.
排除标准
- •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.
研究组 & 干预措施
Scalpel incision
Upper eyelid blepharoplasty performed using scalpel skin incision.
干预措施: Scalpel incision (Procedure)
Electrocautery incision
Upper eyelid blepharoplasty performed using electrocautery incision.
干预措施: Electrocautery incision (Procedure)
结局指标
主要结局
Skin excision time
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Fatma Poslu Karademir
Ophthalmologist
Beyoglu Eye Research and Education Hospital