Electrocautery Versus Scalpel Incision in Upper Eyelid Blepharoplasty

NCT07749846 | Completed

• 1 other identifier: BLEPH-25-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatochalasis; Blepharoplasty

Keywords

Upper eyelid blepharoplasty; Electrocautery; Scalpel; Randomized controlled trial; Eyelid surgery; Scar healing; Wound healing; Oculoplastic surgery; Contralateral study

Outcome Measures

Primary Outcomes (6)

• Skin excision time

  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.

  During surgery (intraoperative)

• Intraoperative bleeding

  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.

  During surgery (intraoperative)

• Postoperative ecchymosis

  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 day 1, week 1, month 1, month 3, and month 6

• Postoperative edema

  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.

  Postoperative day 1, week 1, month 1, month 3, and month 6

• Scar visibility

  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.

  Postoperative months 1, 3, and 6

• Hyperpigmentation and hypopigmentation

  Postoperative hypopigmentation and hyperpigmentation were evaluated separately for each eyelid using standardized postoperative photographs and recorded as present or absent by masked observers.

  Postoperative months 1, 3, and 6

Secondary Outcomes (2)

• 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

Study Arms (2)

Electrocautery incision

EXPERIMENTAL

Upper eyelid blepharoplasty performed using electrocautery incision.

Procedure: Electrocautery incision

Scalpel incision

ACTIVE COMPARATOR

Upper eyelid blepharoplasty performed using scalpel skin incision.

Procedure: Scalpel incision

Interventions

Electrocautery incision PROCEDURE

Skin incision performed using electrocautery during upper eyelid blepharoplasty.

Electrocautery incision

Scalpel incision PROCEDURE

Skin incision performed using a scalpel during upper eyelid blepharoplasty.

Scalpel incision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older.
• Diagnosis of upper eyelid dermatochalasis.
• Scheduled to undergo bilateral upper eyelid blepharoplasty.
• Ability to provide written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beyoglu Eye Research and Education Hospital: lead

Study Sites (1)

University of Health Sciences Beyoğlu Eye Training and Research Hospital

Istanbul, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmologist

Model Details: Each participant underwent bilateral upper eyelid blepharoplasty. One eyelid was randomized to electrocautery incision and the contralateral eyelid to scalpel incision, allowing each participant to serve as his or her own control.

Study Record Dates

• First Submitted: August 2, 2026
• First Posted: August 6, 2026
• Study Start: September 15, 2025
• Primary Completion: April 24, 2026
• Study Completion: April 24, 2026
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)