Safety and Efficiency of Electrocautery De-Epithelization in Mammoplasty

NCT ID: NCT06870695

Last Updated: 2025-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-02-25

Brief Summary

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

Detailed Description

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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.

Conditions

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Safety Efficiency Electrocautery De-Epithelization Mammoplasty

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Electrocautery group

Patients undergoing standard surgical de-epithelization with electrocautery.

Electrocautery

Intervention Type PROCEDURE

Patients undergoing standard surgical de-epithelization with electrocautery.

Control group

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

Surgical blade by scalpel

Intervention Type PROCEDURE

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

Interventions

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Electrocautery

Patients undergoing standard surgical de-epithelization with electrocautery.

Intervention Type PROCEDURE

Surgical blade by scalpel

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Hamdy Elghazaly

Lecturer of Plastic and Reconstructive Surgery, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University

Tanta, El-Gharbia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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36264PR1061/1/25

Identifier Type: -

Identifier Source: org_study_id

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