Clinical trial NCT06243796: Seroma Formation After Modified Radical Mastectomy With Flap Fixation Technique in Breast Cancer Patients
Official title: Seroma Formation After Modified Radical Mastectomy With Flap Fixation Technique in Breast Cancer Patients: Nakhon Phanom Hospital - a Single Blinded Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast-cancer
Keywords: Mastectomy flap fixation
Lead sponsor: Nakhon Phanom Hospital
Sponsor class: OTHER_GOV
First posted: 2024-02-06
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blinded randomized control trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Seroma formation
timeFrame: Every day for 7 days after operation, after discharge 7 days, 15 days, 21 days, 42 days, 63 days, 84 days
Secondary outcomes:
measure: Wound infection
timeFrame: Every day for 7 days after operation, after discharge 7 days, 15 days, 21 days, 42 days, 63 days, 84 days
Other outcomes:
Locations:
city: Nakhon Phanom
country: Thailand
facility: Nakhon Phanom hospital
Study officials:
affiliation: Nakhon Phanom Hospital
name: Natawan Hunpayon, MD
role: PRINCIPAL_INVESTIGATOR
References: