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.

Study Overview

• Status: Completed
• Conditions: Safety; Mammoplasty; Efficiency; Electrocautery; De-Epithelization
• Intervention / Treatment: Procedure: Electrocautery; Procedure: Surgical blade by scalpel

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.

• Study Type: Observational
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Electrocautery group; Patients undergoing standard surgical de-epithelization with electrocautery.	Procedure: Electrocautery; Patients undergoing standard surgical de-epithelization with electrocautery.
Control group; Patients undergoing standard surgical de-epithelization using surgical blade by scalpel.	Procedure: Surgical blade by scalpel; Patients undergoing standard surgical de-epithelization using surgical blade by scalpel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	Operative time (time taken from skin incision to completion of skin closure). Operative time will be measured for each breast	Intraoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	3 days after surgery
De-epithelization time	De-epithelization time will be recorded.	Intraoperatively
Time to achieve hemostasis	The time to achieve hemostasis will be assessed.	Intraoperatively
Duration of drain placement	Duration of drain placement will be recorded.	Intraoperatively
Blood loss	Blood loss will be assessed by weighing the swabs that will be used during the pedicle de-epithelialization process.	Intraoperatively
Wound healing time	Wound healing time will be recorded.	6 weeks after surgery
Incidence of adverse events	The incidence of adverse events such as flap necrosis, hematoma, seroma, and surgical site infection will be recorded.	6 weeks after surgery

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): February 25, 2025
• Study Completion (Actual): February 25, 2025

Study Registration Dates

• First Submitted: March 5, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 36264PR1061/1/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Access Criteria: After the end of study for one year.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No