A Prospective Randomized Controlled Study on Minimally Invasive Breast Effects Between the Modified Local Compression Bandaging Method and the Traditional Whole Breast Compression Bandaging Method
Phase: NA
Conditions: Minimally Invasive Mammary Gland Vacuum-Assisted Biopsy
Sponsor: Guangdong Provincial People's Hospital

Research Protocol
A Prospective Randomized Controlled Study of the Modified Local
Compression Bandaging Method and the Traditional Whole Breast
Compression Bandaging Method in Minimally Invasive Breast Surgery
1.Research Background
Due to the relatively large trauma to the breast caused by traditional
general
anesthesia
surgery,
long
recovery
time,
high
incidence
of
postoperative complications, and the fear of general anesthesia surgery
among patients, the Mammotome minimally invasive rotational resection
technique has emerged. The advantages of this minimally invasive breast
surgery are quite prominent, mainly manifested as visualization, small
incisions, and safety and reliability. Currently, the commonly used
bandaging method after minimally invasive breast surgery in clinical
practice is the whole breast compression bandaging method. One or two
pieces of sterile loose gauze are kneaded into a gauze ball and pressed on
the residual cavity. Then, 5 to 8 pieces of loose gauze are continuously used
to stack gauze balls within a 5-cm diameter around the wound for bandaging.
Finally, an elastic bra is used for compression bandaging for one day. The
elastic bra is a special compression elastic bandage for breast surgery,
aiming to achieve auxiliary therapeutic effects such as eliminating the cavity
and protecting the surgical incision. However, in the process of clinical
practice, it has been found that this bandaging method brings great
discomfort to patients. It is not only reflected in varying degrees of skin
itching on the covered skin, with a relatively high occurrence of local red
rashes, but also affects the patients' breathing. The vast majority of patients
complain of pain and discomfort due to the tightness on the chest and back,
being restless while sitting or lying down. At night, they can only sleep in a
semi-sitting position and are largely unable to enter deep sleep, seriously
affecting the patients' daily activities and sleep. In order to improve the
patients' experience and reduce their discomfort as much as possible, the
medical and nursing joint team has explored and modified the compression
bandaging method after minimally invasive surgery and found that the local
compression bandaging method is more comfortable. That is, one or two
pieces of loose gauze are kneaded into a gauze ball to replace multiple gauze
balls and placed in the residual cavity. Then, elastic medical adhesive tape is
used for local compression and sticking. Finally, a pure cotton clean towel is
placed inside the elastic bra and the elastic bra is worn for one day. The
results of a pre-experiment with 50 cases show that among the patients using
the local compression bandaging method, there is no occurrence of wound
hematoma, and their skin itching, chest and back pain, comfort level, and

sleep quality have all been improved. In order to further compare the
application effects of the whole breast compression bandaging method and
the local compression bandaging method, our research team intends to
conduct a controlled study of these two methods.
2. Research Objectives
Research objective: Through a randomized controlled study, compare and
study the curative effects of the whole breast bandaging method and the
local bandaging method during the perioperative period of minimally
invasive breast surgery. Evaluate the impacts of the two bandaging methods
on the wound healing status after minimally invasive breast surgery, the
incidence of hematoma, the patients' comfort level, and the incidence of
patients' pain.
3. Research Design
①Randomized controlled trial. Put the number tags 1 and 2 into two
identical envelopes respectively. The number tag 1 represents the whole
breast compression bandaging method as the control group, and the number
tag
2 represents
the
local
compression
bandaging
method
as
the
experimental group. The patients included in the study randomly draw an
envelope and enter the corresponding group according to the tag they draw.
The patients' surgeries are all scheduled during the non-menstrual period.
On the first day after the surgery, the patients in both groups fill in the
questionnaire QR code. The content of the questionnaire QR code includes
general information (including: name, age, underlying diseases, educational
background, etc.), pain rating scale, comfort scale, whether there is a
hematoma, and a patient satisfaction questionnaire. Use breast color Doppler
ultrasound to check the wound healing and hematoma status at 2 weeks and
3 months after the surgery respectively.
②The control group uses the whole breast bandaging method: Knead 1 to 2
pieces of sterile loose gauze into a gauze ball and press it on the residual
cavity. Then, continue to use 5 to 8 pieces of loose gauze to stack gauze balls
within a 5-cm diameter around the wound for bandaging, and finally use an
elastic bra for compression bandaging. The time for compression bandaging
with the elastic bra is 24 hours.
③The experimental group uses the local bandaging method: Knead one or
two pieces of loose gauze into a gauze ball to replace multiple gauze balls
and place it in the residual cavity. Then, use elastic medical adhesive tape
for local compression and sticking. Finally, place a pure cotton clean towel
inside the elastic bra and wear the elastic bra for one day.
④The elastic bras involved above are all purchased by the patients
themselves. The elastic bra is a product with a sealed package and can be
directly used after being opened according to the instructions. The material
of the elastic bra is made of spandex elastic fabric, with a front row of snap

buttons. There is a compression band at the front end of the bra, which
adopts a double parallel band design and can adjust the local pressure
intensity. The compression band can be pressurized in parallel or crossed.
Crossed pressurization can be used for local pressurization to accelerate the
repair of the residual cavity. The functions of the elastic bra are: 1.
Effectively stop bleeding after surgery and reduce postoperative exudation; 2.
Apply scientific multi-point compression to prevent tissue necrosis; 3.
Repair the surgical wound and promote wound healing. The wearing method
of the elastic bra: After laying out the elastic bra flat, pull the snap buttons to
the front of the chest and fasten them. Stick the Velcro of the left and right
shoulder straps of the patient. Forcefully press the compression band at the
front end on the side with the wound backward and stick it firmly. For the
side without the wound, it can be generally stuck. Patients with different
chest circumferences and weights choose different models of elastic bras, M
size (45-55 kg) and L size (55-65 kg).
⑤This study is carried out by the minimally invasive team led by Provide
Health Care of provide. The team consists of 1 chief physician and 4 nurses,
and the postoperative bandaging of the minimally invasive wound and the
inspection of the bandaging effect are completed under the guidance and
assistance of Surgeon .
4.Research Subjects
Patients scheduled to undergo ultrasound-guided minimally invasive
rotational resection of the breast.
Inclusion Criteria:
1
Age between 18 and 70 years old;
2
The ultrasound report shows category or category 4A;
3
Patients without allergy to medical adhesive tape;
4
Patients without hematopoietic system diseases such as bleeding
tendency and coagulation dysfunction;
5
Willingly participate in the investigation and study;
6
No fever and no infection found during the admission physical
examination.
Exclusion Criteria:
1
Patients with malignant breast tumors;
2
Patients with mental illnesses;
3
Patients who do not meet the indications for minimally invasive

surgery according to the examination results.
5. Research Endpoints
1. Primary research endpoint: The incidence of hematoma in patients. 2.
Secondary research endpoints: The patients' comfort level, the incidence of
pain, the satisfaction with medical treatment, medical adhesive-related skin
damage, and safety.
6. Research Risks
Both groups of patients may experience subcutaneous hematoma, itching,
pain, poor breathing, etc. If any damage related to the study occurs, it will
be handled in accordance with relevant national laws and regulations.
7.
Definitions
of
Research
Endpoints
and
Related
Outcome
Judgments
1
Comfort level: Comfort scale: Use the Kolcaba General Comfort
Questionnaire (GCQ) to evaluate the patients' comfort level, including four
dimensions
of
physiology,
psychology,
spirit,
social
culture,
and
environment, with a total of 28 items. The higher the score, the more
comfortable the patient is.
2
Incidence of hematoma in both groups: Postoperative hematoma is
commonly seen within 24 hours after the surgery, often manifested as a local
hard mass in the residual cavity, ecchymosis under the skin, and the patient
complains of severe pain and a feeling of swelling.
3
Incidence of pain in both groups: Defined as the comparison of the
pain of the wound from skin incision to the first day after the surgery and 2
weeks after the surgery.
4
Patient satisfaction: A survey of all patients on our medical staff,
the ward environment, and the overall medical experience from admission to
discharge.
5
Medical adhesive-related skin damage: Observation of related skin
damage caused during the period from fixing the gauze with anti-allergic
medical elastic adhesive tape on the patient to removing the tape one day
later, such as mechanical damage, contact dermatitis, local skin allergy,

tension injury, and epidermal exfoliation injury.
8、Standard Operating Procedure (SOP) for the Surgical Operation
1.Preoperative Ultrasound Localization
A
B
C
D
Picture1. Traditional Whole Breast Compression Bandaging Method
A: Locate the position of the mass before the operation (as indicated by the red
arrow), and resect the mass under the guidance of color Doppler ultrasound; B: After
the mass is resected, perform bandaging. Place several loose gauze balls at the
position of the residual cavity for local compression; C: Cover the residual cavity and
the incision with a sterile cotton pad; D: Finally, put on an elastic bra for compression
bandaging.

Ⅰ
Ⅱ
Picture2：the Modified Local Compression Bandaging Method
Ⅰ
:
The intraoperative operation method remains unchanged. The
postoperative bandaging technique is improved. Ⅱ：finally, just wear an elastic
bra.
9. Sample Size Estimation
The evaluation items of this study include the patients' general
information: two dimensions of age and chest circumference size, four
dimensions of the patients' comfort level, one dimension of the incidence of
patients' hematoma, one dimension of the incidence of pain, one dimension
of the satisfaction with medical treatment, one dimension of medical
adhesive-related skin damage, and three dimensions of safety, totaling 13
items. According to the formula, the number of samples N = the number of
variables × 20 × (1 + 20%) = 13 × 20 × (1 + 20%), and the actual sample size
is 312 people.
10. Statistical Analysis
1
Use the SPSS 25.0 software for statistical analysis. All statistical
tests are two-sided tests, with α = 0.05, and a P value less than 0.05 is
considered statistically significant.
2
Use percentages, means ± standard deviations to describe the
patients' general information.
3
Use rates, frequencies, and percentages to describe the incidences,
and use means ± standard deviations to describe the scores of each
dimension of the comfort level, the incidence of hematoma, the incidence of
pain, the satisfaction with medical treatment, medical adhesive-related skin
damage, and safety.

4
Use t-tests or regression analysis to study the impact of the
patients' general information on the symptoms.
XI. Data Management
All clinical pathological data are consistent with the clinical records. A
Case Report Form (CRF) will be established for each patient.