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

Nakhon Phanom Hospital

Status: Completed

Conditions: Breast-cancer

Treatments: Procedure: Flap fixation technique

Study type: Interventional

Funder types: Other

Identifiers

NCT06243796

39/2566

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

Flap fixation

Experimental group

Description:

After completing the modified radical mastectomy procedure, the researcher will use absorbable suture (vicryl), multiple alternating stitches 2.5 cm apart between the subcutaneous tissues of the skin flaps and the underlying muscles at various parts of the flap and also, at the wound edge.

Treatment:

Procedure: Flap fixation technique

Non flap fixation

No Intervention group

Description:

After mastectomy, the researcher will close the wound in the conventional method.