Safety and Efficiency of Electrocautery De-Epithelization in Mammoplasty

NCT06870695 | Completed

• 1 other identifier: 36264PR1061/1/25
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Safety; Efficiency; Electrocautery; De-Epithelization; Mammoplasty

Outcome Measures

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

  Intraoperatively

Secondary Outcomes (7)

• Degree of pain

  3 days after surgery

• De-epithelization time

  Intraoperatively

• Time to achieve hemostasis

  Intraoperatively

• Duration of drain placement

  Intraoperatively

• Blood loss

  Intraoperatively

Study Arms (2)

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

Electrocautery PROCEDURE

Patients undergoing standard surgical de-epithelization with electrocautery.

Electrocautery group

Surgical blade by scalpel PROCEDURE

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women undergoing mammoplasty
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Age ≥ 18 years.
• Patients undergoing mammoplasty.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Interventions

Electrocoagulation

Intervention Hierarchy (Ancestors)

Cautery; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Plastic and Reconstructive Surgery, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 11, 2025
• Study Start: July 1, 2024
• Primary Completion: February 25, 2025
• Study Completion: February 25, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be available upon a reasonable request from the corresponding author.
• Access Criteria: After the end of study for one year.

Locations

EG (1)