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

Not Applicable

Active, not recruiting

• Conditions: Breast-cancer
• Interventions: Procedure: Flap fixation technique

• Registration Number: NCT06243796
• Lead Sponsor: Nakhon Phanom Hospital

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.

Study Timeline

• Study Start: 2023-12-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-01-29
• Last Update Submitted: 2024-02-05
• Study First Posted: 2024-02-06
• Last Update Posted: 2024-02-07
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flap fixation	Flap fixation technique	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.

Primary Outcome Measures

Name	Time	Method
Seroma formation	Every day for 7 days after operation, after discharge 7 days, 15 days, 21 days, 42 days, 63 days, 84 days	Collection of acute inflammatory exudates in response to surgical trauma and acute phase of wound healing.

Secondary Outcome Measures

Name	Time	Method
Wound infection	Every day for 7 days after operation, after discharge 7 days, 15 days, 21 days, 42 days, 63 days, 84 days	Any clinical signs and symptoms of wound infection, redness , swelling, wound dehiscence, of Fever \> 38 C

Trial Locations

Locations (1)

Nakhon Phanom hospital; 🇹🇭 Nakhon Phanom, Thailand