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Safety and Efficiency of Electrocautery De-Epithelization in Mammoplasty

Safety and Efficiency of Electrocautery De-Epithelization in Mammoplasty

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06870695
Enrollment
100
Registered
2025-03-11
Start date
2024-07-01
Completion date
2025-02-25
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Safety, Efficiency, Electrocautery, De-Epithelization, Mammoplasty

Brief summary

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

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.

Interventions

Patients undergoing standard surgical de-epithelization with electrocautery.

PROCEDURESurgical blade by scalpel

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

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
De-epithelization timeIntraoperativelyDe-epithelization time will be recorded.
Time to achieve hemostasisIntraoperativelyThe time to achieve hemostasis will be assessed.
Duration of drain placementIntraoperativelyDuration of drain placement will be recorded.
Degree of pain3 days after surgeryDegree 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).
Wound healing time6 weeks after surgeryWound healing time will be recorded.
Incidence of adverse events6 weeks after surgeryThe incidence of adverse events such as flap necrosis, hematoma, seroma, and surgical site infection will be recorded.
Blood lossIntraoperativelyBlood loss will be assessed by weighing the swabs that will be used during the pedicle de-epithelialization process.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026