Tanta University
Tanta, El-Gharbia, 31527, Egypt
NCT Number: NCT06870695
The aim of this study is to evaluate safety and efficiency of electrocautery de-epithelization in mammoplasty.
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Notify Me18 year and older
Female
Observational
Tanta, El-Gharbia, 31527, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients undergoing standard surgical de-epithelization with electrocautery.
Patients undergoing standard surgical de-epithelization using surgical blade by scalpel.
Time frame: Intraoperatively
Operative time (time taken from skin incision to completion of skin closure). Operative time will be measured for each breast
Time frame: 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).
Time frame: Intraoperatively
De-epithelization time will be recorded.
Time frame: Intraoperatively
The time to achieve hemostasis will be assessed.
Time frame: Intraoperatively
Duration of drain placement will be recorded.
Time frame: Intraoperatively
Blood loss will be assessed by weighing the swabs that will be used during the pedicle de-epithelialization process.
Time frame: 6 weeks after surgery
Wound healing time will be recorded.
Time frame: 6 weeks after surgery
The incidence of adverse events such as flap necrosis, hematoma, seroma, and surgical site infection will be recorded.
Tanta University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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