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

NCT06243796 | Completed Results

• 1 other identifier: 39/2566
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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. 1.Mastectomy flap fixation
2. 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.

Conditions

Breast-cancer

Keywords

Mastectomy flap fixation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  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.

Study Arms (2)

Flap fixation

EXPERIMENTAL

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

Non flap fixation

NO INTERVENTION

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

Interventions

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

Flap fixation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast cancer (CA Breast) patients plan to modified radical mastectomy
• Operable case, or Resectable case

You may not qualify if:

• 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

Sponsors & Collaborators

• Nakhon Phanom Hospital: lead

Study Sites (1)

Nakhon Phanom hospital

Nakhon Phanom, 48000, Thailand

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr.Kriengkrai Prasert
• Organization: Nakhon Phanom hospital

gpsiam28@gmail.com

+6642199222

Study Officials

• Natawan Hunpayon, MD

  Nakhon Phanom Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The statistician will generate randomization list from block randomization, then concealed envelope
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Single blinded randomized control trial

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 6, 2024
• Study Start: December 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: November 1, 2024
• Last Updated: July 11, 2025
• Results First Posted: July 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 1 year after publication for a period of 2 years
• 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.

Locations

TH (1)