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Completed

NCT Number: NCT07749846

Electrocautery Versus Scalpel Incision in Upper Eyelid Blepharoplasty

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.

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Key information

Conditions

Dermatochalasis Blepharoplasty Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Cutis Laxa Genetic Diseases, Inborn Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences Beyoğlu Eye Training and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

electrocautery incision

Procedure

Skin incision performed using electrocautery during upper eyelid blepharoplasty.

Scalpel incision

Procedure

Skin incision performed using a scalpel during upper eyelid blepharoplasty.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  1. Corneal epithelial staining

    Time frame: Postoperative day 1, week 1, month 1, month 3, and month 6

    Corneal epithelial staining was evaluated using the Oxford grading scale (0-5) during slit-lamp examination. Higher scores indicated more severe corneal epithelial damage.

  2. Global Aesthetic Improvement Scale (GAIS)

    Time frame: Postoperative day 1, week 1, month 1, month 3, and month 6

    Global aesthetic improvement was assessed by masked observers using the Global Aesthetic Improvement Scale (GAIS), a 5-point scale ranging from 1 (worse) to 5 (very much improved), based on comparison of postoperative and preoperative photographs.

Sponsors and collaborators

Lead sponsor

Beyoglu Eye Research and Education Hospital

Other Gov

Registry information

Official study title

Comparison of Electrocautery and Scalpel for Upper Eyelid Blepharoplasty Incision: A Prospective Randomized Contralateral Comparative Study

Acronym: ELECT-BLEPH

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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