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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast-cancer
• Intervention / Treatment: Procedure: Flap fixation technique

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Nakhon Phanom, Thailand, 48000
    • Nakhon Phanom Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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
No Intervention: Non flap fixation; After mastectomy, the researcher will close the wound in the conventional method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroma Formation	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.	Every day for 7 days post operative period and after discharge 7, 15, 21, 42, 63, 84 days during follow up period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication After Surgery 1. Wound Infection 2. Joint Stiffness 3. Visit Before the Appointment Date	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.	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.

Collaborators and Investigators

• Sponsor: Nakhon Phanom Hospital
• Investigators: Principal Investigator: Natawan Hunpayon, MD, Nakhon Phanom Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): November 1, 2024

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Actual): February 6, 2024

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: June 22, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Mastectomy flap fixation
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 39/2566

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identify data
• IPD Sharing Time Frame: 1 year after publication for a period of 2 years
• IPD Sharing Access Criteria: Access to trial Individual Patient Data (IPD) can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of research proposal and statistical analysis plan (SAP) and execution of Data Sharing Agreement (DSA). For more information or to submit a request, please contact e-mail: sutthichain@gmail.com.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No