N/A
N=68
Seroma Formation After Modified Radical Mastectomy With Flap Fixation Technique in Breast Cancer Patients
Breast-cancer
Bottom Line
View on ClinicalTrials.gov: NCT06243796 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Seroma Formation — 54.27; 59.56; 102.21; 117.94 ml — p=<0.005
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Flap fixation technique (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Nakhon Phanom Hospital
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Seroma Formation |
54.27; 59.56; 102.21; 117.94; 85.00; 94.24 | <0.005 sig |
| SECONDARY Complication After Surgery 1. Wound Infection 2. Joint Stiffness 3. Visit Before the Appointment Date |
0; 2; 3; 2; 0; 6 | <0.05 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT06243796). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.