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Clinical Trial Summary

The goal of this clinical trial is to evaluate the effectiveness of mastectomy flap fixation in breast cancer patients. The main questions it aims to answer are: - To compare seroma formation after mastectomy flap fixation with conventional surgery in breast cancer patients Participants will be randomly divided into 2 groups, 1. Mastectomy flap fixation 2. Conventional surgery with non flap fixation. Researchers will record the amount and color of drainage fluid, patient and tumor characteristics, and operative related factor after surgery. Researchers will compare with conventional surgery to see if seroma formation, and wound infection.


Clinical Trial Description

Seroma is collection of blood plasma or lymphatic fluid under skin flap or axillary dead space. It occurred after modified radical mastectomy. Patient will have subcutaneous swelling or edema which be confirmed by physical examination or bedside ultrasound. It categorized by common terminology criteria for adverse events version 5.0 for 3 grades. 1. asymptomatic 2. symptomatic with medical intervention or simple aspiration 3. symptomatic with required interventional radiology or operative intervention. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06243796
Study type Interventional
Source Nakhon Phanom Hospital
Contact
Status Active, not recruiting
Phase N/A
Start date December 1, 2023
Completion date June 30, 2024

See also
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