DermatochalasisELECT-BLEPHNCT07749846
Electrocautery Versus Scalpel Incision in Upper Eyelid Blepharoplasty
A study testing Electrocautery incision and Scalpel incision in people with Dermatochalasis and Blepharoplasty, run by Beyoglu Eye Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatochalasis, Blepharoplasty
- What is being tested?
- Electrocautery incision and Scalpel incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2025to 24 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Diagnosis of upper eyelid dermatochalasis.
- Scheduled to undergo bilateral upper eyelid blepharoplasty.
- Ability to provide written informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Beyoğlu Eye Training and Research Hospital
Istanbul, Istanbul
About this study
Official title: Comparison of Electrocautery and Scalpel for Upper Eyelid Blepharoplasty Incision: A Prospective Randomized Contralateral Comparative Study
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.
Read the 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.
- Conditions
- Dermatochalasis, Blepharoplasty
- Being tested
- Electrocautery incision, Scalpel incision
- Keywords
- Upper eyelid blepharoplasty, Electrocautery, Scalpel, Randomized controlled trial, Eyelid surgery, Scar healing, Wound healing, Oculoplastic surgery, Contralateral study
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrocautery incisionProcedure or surgery
Skin incision performed using electrocautery during upper eyelid blepharoplasty.
Scalpel incisionProcedure or surgery
Skin incision performed using a scalpel during upper eyelid blepharoplasty.
| Study group | Role | What they receive |
|---|---|---|
| Electrocautery incision | Experimental | Upper eyelid blepharoplasty performed using electrocautery incision. Receives: Procedure: Electrocautery incision |
| Scalpel incision | Active comparator | Upper eyelid blepharoplasty performed using scalpel skin incision. Receives: Procedure: Scalpel incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Postoperative months 1, 3, and 6
Secondary outcomes (2)
Corneal epithelial staining
Corneal epithelial staining was evaluated using the Oxford grading scale (0-5) during slit-lamp examination. Higher scores indicated more severe corneal epithelial damage.
Measured: Postoperative day 1, week 1, month 1, month 3, and month 6
Global Aesthetic Improvement Scale (GAIS)
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.
Measured: Postoperative day 1, week 1, month 1, month 3, and month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start15 Sep 2025
- Primary completion24 Apr 2026
- Study completion24 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatochalasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beyoglu Eye Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fatma Poslu Karademir, Beyoglu Eye Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749846
- Sponsor's protocol ID
- BLEPH-25-02
- Acronym
- ELECT-BLEPH
- Status last verified
- Aug 2026
- First submitted
- 2 Aug 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Electrocautery and Scalpel for Upper Eyelid Blepharoplasty Incision: A Prospective Randomized Contralateral Comparative Study
- ClinicalTrials.gov ID
- NCT07749846
- Acronym / sponsor ID
- ELECT-BLEPH / BLEPH-25-02
- Conditions
- Dermatochalasis, Blepharoplasty
- Keywords
- Upper eyelid blepharoplasty, Electrocautery, Scalpel, Randomized controlled trial, Eyelid surgery, Scar healing, Wound healing, Oculoplastic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Beyoglu Eye Research and Education HospitalOther government
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 24 Apr 2026 (actual)
- Study completion
- 24 Apr 2026 (actual)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Electrocautery incision | Experimental | Procedure: Electrocautery incisionUpper eyelid blepharoplasty performed using electrocautery incision. |
| Scalpel incision | Active comparator | Procedure: Scalpel incisionUpper eyelid blepharoplasty performed using scalpel skin incision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older.
- Diagnosis of upper eyelid dermatochalasis.
- Scheduled to undergo bilateral upper eyelid blepharoplasty.
- Ability to provide written informed consent.
Key exclusion criteria (7 listed)
- Previous eyelid surgery.
- History of eyelid trauma.
- Blepharochalasis syndrome.
- Congenital eyelid anomalies.
- Coagulation disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrocautery incisionSkin incision performed using electrocautery during upper eyelid blepharoplasty. | Procedure or surgery | Electrocautery incision |
| Scalpel incisionSkin incision performed using a scalpel during upper eyelid blepharoplasty. | Procedure or surgery | Scalpel incision |
Primary outcome
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.
2 secondary outcomes
Corneal epithelial staining
Time frame: Postoperative day 1, week 1, month 1, month 3, and month 6
Global Aesthetic Improvement Scale (GAIS)
Time frame: Postoperative day 1, week 1, month 1, month 3, and month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrocautery incision and Scalpel incision in people with Dermatochalasis and Blepharoplasty, run by Beyoglu Eye Research and Education Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin excision time (time frame: During surgery (intraoperative)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.