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

NCT ID: NCT06243796

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-11-01

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.

Conditions

Breast-cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Flap fixation

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.

Group Type: EXPERIMENTAL

Flap fixation technique

Intervention Type: 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

Non flap fixation

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Flap fixation technique

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Nakhon Phanom Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Natawan Hunpayon, MD

Role: PRINCIPAL_INVESTIGATOR

Nakhon Phanom Hospital

Locations

Nakhon Phanom hospital

Nakhon Phanom, , Thailand

Countries

Thailand

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

39/2566

Identifier Type: -

Identifier Source: org_study_id