Seroma Formation After Modified Radical Mastectomy With Flap Fixation Technique in Breast Cancer Patients

Not Applicable

Completed

Brief 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.

Detailed 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Having medical bleeding tendency e.g., Idiopathic Thrombocytopenia (ITP), leukemia, other bleeding disorder
Immunocompromised e.g., HIV, Systemic Lupus Erythematosus (SLE), liver cirrhosis, immunosuppressive drug
Other modified radical mastectomy whom required reconstruction, flap coverage e.g., Transverse Rectus Abdominis Musculocutaneous (TRAM) flap, Latissimus Dorsi (LD) flap
Past history of mammoplasty, augmentation
Past history of axillary lymphatic system operation
Pregnant women

Primary Outcome Measures

Name	Time	Method
Seroma Formation	Every day for 7 days post operative period and after discharge 7, 15, 21, 42, 63, 84 days during follow up period.	Every day for 7 days post operative period, fluid from drains was recorded (ml) daily. After discharge during follow up period, seroma formation was observed if seroma was observed, aspiration was performed and recorded.

Secondary Outcome Measures

Name	Time	Method
Complication After Surgery 1. Wound Infection 2. Joint Stiffness 3. Visit Before the Appointment Date	Data were assessed 7 days after operation, after discharge 7 days, 15 days, 21 days, 42 days, 63 days, 84 days. Data from any time point were combined by counted and sum number of specific outcome of interest.	1. wound infection; any clinical signs and symptoms of wound infection, redness , swelling, wound dehiscence, of Fever \> 38 C. 2. Joint stiffness; limitation of range of movement of Shoulder same side of mastectomy. 3. Visit before the appointment date; any visit relevant surgical conditions before appointment.