Trial Outcomes & Findings for Seroma Formation After Modified Radical Mastectomy With Flap Fixation Technique in Breast Cancer Patients (NCT NCT06243796)
NCT ID: NCT06243796
Last Updated: 2025-07-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
Every day for 7 days post operative period and after discharge 7, 15, 21, 42, 63, 84 days during follow up period.
Results posted on
2025-07-11
Participant Flow
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 in Nakhonphanom hospital were screened
Excluded accidental finding liver cirrhosis before surgery (n=1), plan to move another province (n=1)
Participant milestones
| Measure |
Flap Fixation (n=34)
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.
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
|
Non Flap Fixation (n=34)
After mastectomy, the researcher will close the wound in the conventional method.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
34
|
|
Overall Study
COMPLETED
|
34
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Seroma Formation After Modified Radical Mastectomy With Flap Fixation Technique in Breast Cancer Patients
Baseline characteristics by cohort
| Measure |
Flap Fixation
n=34 Participants
Average age was 53±14 years. 13 patients with class I obesity (BMI \> 25kg/m2) and above. 5 (14.7%)patients received neoadjuvant chemotherapy. Average operative time were 57±10 minutes. Average blood loss was 33.53±13.23 ml.
Most of breast cancer cell type in this group was invasive ductal carcinoma = 32. Average tumor size in group A was 3.5 cm. Most of patients in this group were diagnosed in stage 2A, 14(41.18%).1 patients had distance metastasis, (2.94%).
|
Non Flap Fixation
n=34 Participants
Average 58±10 years. 13 patients with class I obesity (BMI \> 25kg/m2) and above. 9 (26.47%) patients received neoadjuvant chemotherapy. Average operative time was 58±10 minutes. Average blood loss was 35.88±17.60 ml.
Most of breast cancer cell type in this group was invasive ductal carcinoma = 31 Average tumor size 4.09 cm. Most of patients in this group were diagnosed in stage 2A, 12 (35.29%). 4 (11.76%) patients had distance metastasis.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 24 • n=5 Participants
|
58 years
STANDARD_DEVIATION 10 • n=7 Participants
|
56 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
34 participants
n=5 Participants
|
34 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
Co-morbidity
|
18 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Body mass index
|
24.59 kg/m2
STANDARD_DEVIATION 3.84 • n=5 Participants
|
23.91 kg/m2
STANDARD_DEVIATION 4.49 • n=7 Participants
|
24.23 kg/m2
STANDARD_DEVIATION 4.16 • n=5 Participants
|
|
Neo-adjuvant chemotherapy
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every day for 7 days post operative period and after discharge 7, 15, 21, 42, 63, 84 days during follow up period.Population: Analysis population is patients whom randomized were performed operation as randomized and have data during follow up period.
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.
Outcome measures
| Measure |
Flap Fixation
n=34 Participants
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.
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
|
Non Flap Fixation
n=34 Participants
After mastectomy, the researcher will close the wound in the conventional method.
|
|---|---|---|
|
Seroma Formation
post operative day 0
|
54.27 ml
Standard Deviation 27.47
|
59.56 ml
Standard Deviation 49.78
|
|
Seroma Formation
post operative day 1
|
102.21 ml
Standard Deviation 40.02
|
117.94 ml
Standard Deviation 43.14
|
|
Seroma Formation
post operative day 2
|
85.00 ml
Standard Deviation 40.82
|
94.24 ml
Standard Deviation 39.06
|
|
Seroma Formation
post operative day 3
|
63.38 ml
Standard Deviation 26.90
|
82.50 ml
Standard Deviation 45.75
|
|
Seroma Formation
post operative day 4
|
53.68 ml
Standard Deviation 24.81
|
60.29 ml
Standard Deviation 29.64
|
|
Seroma Formation
post operative day 5
|
45.59 ml
Standard Deviation 23.05
|
55.00 ml
Standard Deviation 28.37
|
|
Seroma Formation
post operative day 6
|
30.59 ml
Standard Deviation 18.37
|
42.06 ml
Standard Deviation 23.36
|
|
Seroma Formation
post operative day 7
|
15.44 ml
Standard Deviation 14.27
|
26.18 ml
Standard Deviation 21.61
|
|
Seroma Formation
Follow up 7 days
|
40.00 ml
Standard Deviation 18.26
|
86.19 ml
Standard Deviation 56.88
|
|
Seroma Formation
Follow up 15 days
|
20.00 ml
Standard Deviation 0.00
|
72.50 ml
Standard Deviation 55.00
|
|
Seroma Formation
Follow up 21 days
|
0.00 ml
Standard Deviation 0.00
|
72.50 ml
Standard Deviation 55.00
|
|
Seroma Formation
Follow up 42 days
|
0.00 ml
Standard Deviation 0.00
|
86.25 ml
Standard Deviation 31.98
|
|
Seroma Formation
Follow up 63 days
|
0.00 ml
Standard Deviation 0.00
|
30.00 ml
Standard Deviation 0.00
|
|
Seroma Formation
Follow up 84 days
|
0.00 ml
Standard Deviation 0.00
|
0.00 ml
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: 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.1. wound infection; any clinical signs and symptoms of wound infection, redness , swelling, wound dehiscence, of Fever \> 38 C. 2. Joint stiffness; limitation of range of movement of Shoulder same side of mastectomy. 3. Visit before the appointment date; any visit relevant surgical conditions before appointment.
Outcome measures
| Measure |
Flap Fixation
n=34 Participants
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.
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
|
Non Flap Fixation
n=34 Participants
After mastectomy, the researcher will close the wound in the conventional method.
|
|---|---|---|
|
Complication After Surgery 1. Wound Infection 2. Joint Stiffness 3. Visit Before the Appointment Date
wound infection
|
0 Participants
|
2 Participants
|
|
Complication After Surgery 1. Wound Infection 2. Joint Stiffness 3. Visit Before the Appointment Date
joint stiffness
|
3 Participants
|
2 Participants
|
|
Complication After Surgery 1. Wound Infection 2. Joint Stiffness 3. Visit Before the Appointment Date
visit before follow up date
|
0 Participants
|
6 Participants
|
Adverse Events
Flap Fixation (n=34)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Non Flap Fixation (n=34)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Flap Fixation (n=34)
n=34 participants at risk
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.
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
|
Non Flap Fixation (n=34)
n=34 participants at risk
After mastectomy, the researcher will close the wound in the conventional method.
|
|---|---|---|
|
Infections and infestations
Wound infection
|
0.00%
0/34 • 3 months after operation
wound infection, joint stiffness, visit before appointment
|
5.9%
2/34 • Number of events 2 • 3 months after operation
wound infection, joint stiffness, visit before appointment
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
8.8%
3/34 • Number of events 3 • 3 months after operation
wound infection, joint stiffness, visit before appointment
|
5.9%
2/34 • Number of events 2 • 3 months after operation
wound infection, joint stiffness, visit before appointment
|
|
Injury, poisoning and procedural complications
visit before appointment
|
0.00%
0/34 • 3 months after operation
wound infection, joint stiffness, visit before appointment
|
17.6%
6/34 • Number of events 6 • 3 months after operation
wound infection, joint stiffness, visit before appointment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place