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Completed

NCT Number: NCT06243796

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

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.

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Key information

Conditions

Breast-cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nakhon Phanom hospital

Nakhon Phanom, 48000, Thailand

About this study

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.

  • asymptomatic
  • symptomatic with medical intervention or simple aspiration
  • symptomatic with required interventional radiology or operative intervention.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flap fixation technique

Procedure

After complete the modified radical mastectomy procedure, the researcher will use absorbable sutures (vicryl), multiple alternating stitched 2.5 cm apart between the subcutaneous of the flap and underlying muscle

Primary outcomes

  1. Seroma Formation

    Time frame: 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 outcomes

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

    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.

    • wound infection; any clinical signs and symptoms of wound infection, redness , swelling, wound dehiscence, of Fever > 38 C.
    • Joint stiffness; limitation of range of movement of Shoulder same side of mastectomy.
    • Visit before the appointment date; any visit relevant surgical conditions before appointment.

Sponsors and collaborators

Lead sponsor

Nakhon Phanom Hospital

Other Gov

Registry information

Official study title

Seroma Formation After Modified Radical Mastectomy With Flap Fixation Technique in Breast Cancer Patients: Nakhon Phanom Hospital - a Single Blinded Randomized Control Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 6, 2024
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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