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

Title Seroma formation after modified radical mastectomy with flap fixation technique 
in breast cancer patients: Nakhonphanom hospital – a single blinded randomized 
control trial. 
NCT06243796 
10 November 2023 
Methods 
 
A single-blinded randomized control trial was conducted between December 2023 to 
June 2024. All operable breast cancer patients who were 18 years old and over, early and 
locally advance breast cancer who underwent modified radical mastectomy by single 
surgeon who has responsibility at breast clinic in Nakhonphanom hospital were screened.  
 
Inclusion criteria 
1. All operable breast cancer patients who were 18 years old and over. 
2. Early and locally advance breast cancer who underwent modified radical 
mastectomy. 
3. Operable case, resectable case.  
 
Exclusion criteria 
1. Pregnant women. 
2. Patients who did not consent to participate in this study.  
3. Immunocompromise patients. 
4. Patients who need oncoplastic reconstruction, previous aesthetic breast surgery or 
previous lymphatic system surgery at axillary area.  
5. Patients with coagulopathy problems such as liver cirrhosis or bone marrow 
dysfunction. (patients taking aspirin were included) 
6. Patients who were lost to follow up or have serious medical complication during 
admission. 
 
Locally advanced breast cancer patients will receive neoadjuvant chemotherapy 
about 4 cycles until the size of tumors have decreased before surgery. The sample size was 
68 patients. All patients were divided randomly to 2 groups, flap fixation group (group A) and 
conventional group (group B), equally (34 in each group). All patients were checked before 
general anesthesia according to anesthetic guideline and received antibiotic prophylaxis 30 

minutes before surgery. MRM was performed, skin flaps were dissected by monopolar 
electrocautery, axillary lymph node dissection was performed by ligation and monopolar 
electrocautery. Bleeding was checked and stopped by ligation and monopolar 
electrocautery. Close suction drainages (Radivac drain) were placed above pectoralis muscle 
and at axillary area. In flap fixation group, absorbable suture (polyglactin 3-0) were sutured 
between skin flaps and pectoralis muscle. Sutures were fixed about 2-3 cm intervals in two 
or three rows, upper and lower skin flap. The lateral wall of axillary area was sutured with 
the same materials between the fascia of the serratus anterior and axillary wall. In 
conventional group, skin was closed without fixation technique. Both groups, skin was closed 
subcuticular layer and dermis with absorbable suture (polyglactin 3-0 and 4-0) in two layers. 
All assistant nurse were nurses who have the experience in this operation.  
The post-operative period, fluid from drains was recorded daily. All patients were 
admitted at surgery ward and were cared as standard nursing care guideline. All patients 
were consulted to physiotherapist for exercise. The drains will be removed at the 7th day 
after operation. After discharge from hospital, all patients were followed up at outpatient 
department on the 7th – 10th day, 15th- 20th day, then every 3 weeks until 3 months. 
Distance metastasis work up was investigated and adjuvant therapy was considered for all 
patients if indicated.  
 
During follow up period, seroma formation and late-post operative complication 
were observed, including wound infection, wound dehiscence, hematoma and joint stiffness. 
Seroma was examined by   clinical examination, bedside ultrasound or tap aspiration. 
Asymptomatic seroma which not require any treatment is labelled as grade 1. Symptomatic 
seroma requiring needle aspiration is labelled as grade 2. Symptomatic seroma requiring 
surgical intervention is labelled as grade 3. 
 
Data collection format 
 
Data were collected from history talking, medical records, operative notes and 
records and information in follow up period. Data collection format is con-current 
prospective randomization, divide participants into two groups randomly. The first group is 
the conventional group. (non-flap fixation group, n=34) The second group is the intervention 
group (flap fixation group, n=34)  
 
Randomization process 

 
After inform and sign in information sheet, each participant was numbered randomly. 
This number was randomed by computer as 1:1 ratio. The random table was created as 
block of four by the statistician who had no involved in this study.  
 
Concealment information and declaration  
 
The participants were randomized into two groups. They were uninformed their own 
group. Each participant was numbered, respectively. The identification number for this study 
was created randomly by the statistician and enveloped then sent to the nurse. There was 
no one recognize the number and groups. All information was kept in the cabinet in the 
research office, Nakhonphanom hospital where no one can access. In case of the researcher 
suggest that there is a necessary to declare any information of the participants, the 
researcher will report to the institutional ethics committee.  
 
The study was performed with STATA. Patients characteristics, operative information 
and pathologic characteristics were collected and analyzed by statistical distribution, 
frequency, mean and standard deviation (SD). The data were tested for normal distribution 
and the statistically significant variances was p-value < 0.05. Quantitative variables were 
compared by Independent t-test and Wilcoxon Mann-Whitney test. Nominal categorical data 
was compared by Chi-square or Fisher’s exact test. Multilevel mixed-effect Gaussian 
regression was used account for repeated measures for outcomes of interest. Logistic 
regression analysis was used to analyze the factors affecting prolong seroma formation after 
discharge. 
Statistical analysis plan 
Patient’s characteristics, operative information and pathologic characteristics were collected 
and analyzed by statistical distribution, frequency, mean and standard deviation (SD). The 
data were tested for normal distribution and the statistically significant variances was p-
value < 0.05. Quantitative variables were compared by independent t-test and Wilcoxon 
Mann-Whitney test. Nominal categorical data was compared by Chi-square or Fisher’s exact 
test. Multilevel mixed-effect Gaussian regression was used account for repeated measures 
for outcomes of interest. Logistic regression analysis was used to analyze the factors 
affecting prolong seroma formation after discharge.