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Trial Title:
Seroma Formation After Modified Radical Mastectomy With Flap Fixation Technique in Breast Cancer Patients
NCT ID:
NCT06243796
Condition:
Breast-cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Mastectomy flap fixation
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Single blinded randomized control trial
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Masking description:
The statistician will generate randomization list from block randomization, then
concealed envelope
Intervention:
Intervention type:
Procedure
Intervention name:
Flap fixation technique
Description:
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
Arm group label:
Flap fixation
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Nakhon Phanom hospital
Address:
City:
Nakhon Phanom
Zip:
48000
Country:
Thailand
Start date:
December 1, 2023
Completion date:
June 30, 2024
Lead sponsor:
Agency:
Nakhon Phanom Hospital
Agency class:
Other
Source:
Nakhon Phanom Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06243796
