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Completed

NCT Number: NCT06870695

Safety and Efficiency of Electrocautery De-Epithelization in Mammoplasty

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years.
  • Patients undergoing mammoplasty.

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.

Treatment and study plan

Electrocautery

Procedure

Patients undergoing standard surgical de-epithelization with electrocautery.

Surgical blade by scalpel

Procedure

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

Primary outcomes

  1. Operative time

    Time frame: Intraoperatively

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

Secondary outcomes

  1. Degree of pain

    Time frame: 3 days after surgery

    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).

  2. De-epithelization time

    Time frame: Intraoperatively

    De-epithelization time will be recorded.

  3. Time to achieve hemostasis

    Time frame: Intraoperatively

    The time to achieve hemostasis will be assessed.

  4. Duration of drain placement

    Time frame: Intraoperatively

    Duration of drain placement will be recorded.

  5. Blood loss

    Time frame: Intraoperatively

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

  6. Wound healing time

    Time frame: 6 weeks after surgery

    Wound healing time will be recorded.

  7. Incidence of adverse events

    Time frame: 6 weeks after surgery

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

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 11, 2025
Registry last updated
Mar 24, 2025

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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