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CompletedNCT06870695Updated Mar 24, 2025

Safety and Efficiency of Electrocautery De-Epithelization in Mammoplasty

An observational study in Safety, Efficiency and Electrocautery, sponsored by Tanta University. Completed at 1 site in Egypt. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-24.

Sponsored by Tanta University · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
100
Ages
18 Years and older
Sex
Female
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Study summary

The aim of this study is to evaluate safety and efficiency of electrocautery de-epithelization in mammoplasty.

Read the detailed description

Mammoplasty is the fifth most commonly performed by plastic surgeons worldwide to improve symptomatology resulting from macromastia.

One of the key stages in a breast reduction or augmentation surgery is the de-epithelization process. De-epithelialization is the first stage of reduction mammoplasty in techniques that use dermal, dermo-glandular pedicles. Traditional methods of de-epithelization include manual dissection or mechanical scraping as time-consuming and demanding by most surgeons, especially when the breasts are large and when there is no assistant available.

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Conditions studied

  • Safety
  • Efficiency
  • Electrocautery
  • De-Epithelization
  • Mammoplasty
03

In context

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This retrospective study was conducted on 100 females patients aged 18 years or older who were scheduled to undergo mammoplasty at Tanta University Hospitals, Egypt between July 2024 and February 2025

Inclusion criteria

  • Age ≥ 18 years.
  • Patients undergoing mammoplasty.

Exclusion criteria

Exclusion Criteria:

  • Patients with active infections or open wounds at the surgical site.
  • Individuals with known hypersensitivity or adverse reactions to electrocautery.
  • Pregnant or lactating women.
  • Patients with uncontrolled diabetes or coagulation disorders.
  • History of psychiatric illness.
  • Patients undergoing secondary or repeat breast reduction procedures.
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Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • Electrocautery group

    Patients undergoing standard surgical de-epithelization with electrocautery.

    Procedure: Electrocautery

  • Control group

    Patients undergoing standard surgical de-epithelization using surgical blade by scalpel.

    Procedure: Surgical blade by scalpel

Interventions

  • ProcedureElectrocautery

    Patients undergoing standard surgical de-epithelization with electrocautery.

  • ProcedureSurgical blade by scalpel

    Patients undergoing standard surgical de-epithelization using surgical blade by scalpel.

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What researchers measure

Primary outcomes

  1. Operative time

    Operative time (time taken from skin incision to completion of skin closure). Operative time will be measured for each breast

    Time frame: Intraoperatively

Secondary outcomes

  1. Degree of pain

    Degree of pain will be measured using a standard 10-point visual analog pain scale (VAS). The women verbally reported a pain rating for each breast first in the recovery room (within 4 hours of surgical stop) and again at the first follow-up visit (1 to 3 days after surgery).

    Time frame: 3 days after surgery

  2. De-epithelization time

    De-epithelization time will be recorded.

    Time frame: Intraoperatively

  3. Time to achieve hemostasis

    The time to achieve hemostasis will be assessed.

    Time frame: Intraoperatively

  4. Duration of drain placement

    Duration of drain placement will be recorded.

    Time frame: Intraoperatively

  5. Blood loss

    Blood loss will be assessed by weighing the swabs that will be used during the pedicle de-epithelialization process.

    Time frame: Intraoperatively

  6. Wound healing time

    Wound healing time will be recorded.

    Time frame: 6 weeks after surgery

  7. Incidence of adverse events

    The incidence of adverse events such as flap necrosis, hematoma, seroma, and surgical site infection will be recorded.

    Time frame: 6 weeks after surgery

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Study locations

1 site
  • Tanta University
    Tanta, El-Gharbia 31527, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Supporting information: Study protocol

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06870695
Lead sponsor
Tanta University
Responsible party
Mohamed Hamdy Elghazaly (Lecturer of Plastic and Reconstructive Surgery, Faculty of Medicine, Tanta University, Tanta, Egypt., Tanta University) — Principal investigator
First posted
Mar 11, 2025
Start date
Jul 1, 2024
Primary completion
Feb 25, 2025
Completion
Feb 25, 2025
Last update
Mar 24, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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