Safety, Efficiency, Electrocautery, De-Epithelization, Mammoplasty
Conditions
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.
Patients undergoing standard surgical de-epithelization using surgical blade by scalpel.
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Operative time | Intraoperatively | Operative time (time taken from skin incision to completion of skin closure). Operative time will be measured for each breast |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| De-epithelization time | Intraoperatively | De-epithelization time will be recorded. |
| Time to achieve hemostasis | Intraoperatively | The time to achieve hemostasis will be assessed. |
| Duration of drain placement | Intraoperatively | Duration of drain placement will be recorded. |
| Degree of pain | 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). |
| Wound healing time | 6 weeks after surgery | Wound healing time will be recorded. |
| Incidence of adverse events | 6 weeks after surgery | The incidence of adverse events such as flap necrosis, hematoma, seroma, and surgical site infection will be recorded. |
| Blood loss | Intraoperatively | Blood loss will be assessed by weighing the swabs that will be used during the pedicle de-epithelialization process. |
Countries
Egypt