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

Nakhon Phanom Hospital70 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Breast-cancer

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Breast cancer (CA Breast) patients plan to modified radical mastectomy * Operable case, or Resectable case 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

Outcomes

Primary Outcomes

Seroma Formation

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.

Time frame: Every day for 7 days post operative period and after discharge 7, 15, 21, 42, 63, 84 days during follow up period.

Secondary Outcomes

Complication After Surgery 1. Wound Infection 2. Joint Stiffness 3. Visit Before the Appointment Date

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.

Time frame: 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.