Minimally Invasive Mammary Gland Vacuum-Assisted BiopsyNCT06964516
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
A study testing The group using the whole-breast bandaging method and The group using the local bandaging method in people with Minimally Invasive Mammary Gland Vacuum-Assisted Biopsy, run by Guangdong Provincial People's Hospital.
Trial summary
I. 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 patients' fear of general anesthesia surgery, the Mammotome minimally invasive rotary excision surgery has emerged. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Minimally Invasive Mammary Gland Vacuum-Assisted Biopsy
- What is being tested?
- The group using the whole-breast bandaging method and The group using the local bandaging method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 22 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years old.
- The ultrasound report shows category 3 or category 4A.
- Patients without allergy to medical adhesive tape.
- Patients without hematopoietic system diseases such as bleeding tendency and coagulation dysfunction.
- Willingly participate in the investigation and study.
- No fever and no infection found during the admission physical examination.
Who cannot join
- 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.
About this study
- 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 patients' fear of general anesthesia surgery, the Mammotome minimally invasive rotary excision surgery has emerged. This minimally invasive breast surgery has very prominent advantages, 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 sterile loose gauze pieces are kneaded into a gauze ball and pressed on the residual cavity. Then, 5 to 8 loose gauze pieces are continuously stacked with the gauze ball within a 5 cm diameter around the wound for bandaging. Finally, an elastic bra is used for another day of compression bandaging. The elastic bra is a special compression elastic bandage for postoperative breast use to achieve auxiliary therapeutic effects such as clearing the cavity and protecting the surgical incision.
Read more
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, and there are many cases of local red rashes. Moreover, it affects the patients' breathing. The vast majority of patients complain of pain and discomfort caused by the tight binding on the chest and back, feeling restless when sitting or lying down. At night, they can only sleep in a semi-sitting position and are largely unable to enter a deep sleep, seriously affecting the patients' daily activities and sleep conditions.
In order to improve the patients' experience and reduce their discomfort as much as possible, the medical and nursing joint team explored and improved the compression bandaging method after minimally invasive surgery and found that the local compression bandaging method is more comfortable. That is, one or two loose gauze pieces are kneaded into a gauze ball to replace multiple gauze balls and placed at 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.
According to the results of a pre-experiment involving 50 cases, among the patients using the local compression bandaging method, there was no occurrence of wound hematoma, and their skin itching, chest and back pain, comfort level, and sleep conditions were all improved. In order to further compare the application effects of the whole-breast compression bandaging method and the local compression bandaging method, the research team of this study intends to conduct a comparative study of the two methods.
II. Research Objectives Research Objectives: Through a randomized controlled study, compare and study the curative effects of two different bandaging methods, namely 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 situation after minimally invasive breast surgery, the incidence of hematoma, the patients' comfort level, and the incidence of patients' pain.
- Being tested
- The group using the whole-breast bandaging method, The group using the local bandaging method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The group using the whole-breast bandaging methodProcedure or surgery
Use 1 to 2 pieces of sterile loose gauze to knead into a gauze ball, press it on the residual cavity. Then, continue to use 5 to 8 pieces of loose gauze to stack gauze balls within a diameter of 5 cm around the wound for bandaging. Finally, apply compression bandaging with an elastic bra. The time for compression bandaging with the elastic bra is 24 hours.
The group using the local bandaging methodProcedure or surgery
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 just one day.
| Study group | Role | What they receive |
|---|---|---|
| The group using the whole-breast bandaging method | Active comparator | Not described Receives: Procedure: The group using the whole-breast bandaging method |
| The group using the local bandaging method | Experimental | Not described Receives: Procedure: The group using the local bandaging method |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of hematoma in patients: Use breast color Doppler ultrasound to check the wound healing condition and the presence of hematoma
Measured: At 2 weeks and 3 months after the operation respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion22 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimally Invasive Mammary Gland Vacuum-Assisted BiopsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kun Wang, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964516
- Sponsor's protocol ID
- KY2025-202-03
- Status last verified
- May 2025
- First submitted
- 1 May 2025
- Last updated
- 9 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06964516
- Acronym / sponsor ID
- KY2025-202-03
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 22 Jan 2026 (estimated)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 patients' fear of general anesthesia surgery, the Mammotome minimally invasive rotary excision surgery has emerged. This minimally invasive breast surgery has very prominent advantages, 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 sterile loose gauze pieces are kneaded into a gauze ball and pressed on the residual cavity. Then, 5 to 8 loose gauze pieces are continuously stacked with the gauze ball within a 5 cm diameter around the wound for bandaging. Finally, an elastic bra is used for another day of compression bandaging. The elastic bra is a special compression elastic bandage for postoperative breast use to achieve auxiliary therapeutic effects such as clearing 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, and there are many cases of local red rashes. Moreover, it affects the patients' breathing. The vast majority of patients complain of pain and discomfort caused by the tight binding on the chest and back, feeling restless when sitting or lying down. At night, they can only sleep in a semi-sitting position and are largely unable to enter a deep sleep, seriously affecting the patients' daily activities and sleep conditions.
In order to improve the patients' experience and reduce their discomfort as much as possible, the medical and nursing joint team explored and improved the compression bandaging method after minimally invasive surgery and found that the local compression bandaging method is more comfortable. That is, one or two loose gauze pieces are kneaded into a gauze ball to replace multiple gauze balls and placed at 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.
According to the results of a pre-experiment involving 50 cases, among the patients using the local compression bandaging method, there was no occurrence of wound hematoma, and their skin itching, chest and back pain, comfort level, and sleep conditions were all improved. In order to further compare the application effects of the whole-breast compression bandaging method and the local compression bandaging method, the research team of this study intends to conduct a comparative study of the two methods.
II. Research Objectives Research Objectives: Through a randomized controlled study, compare and study the curative effects of two different bandaging methods, namely 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 situation after minimally invasive breast surgery, the incidence of hematoma, the patients' comfort level, and the incidence of patients' pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The group using the whole-breast bandaging method | Active comparator | Procedure: The group using the whole-breast bandaging method |
| The group using the local bandaging method | Experimental | Procedure: The group using the local bandaging method |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 70 years old.
- The ultrasound report shows category 3 or category 4A.
- Patients without allergy to medical adhesive tape.
- Patients without hematopoietic system diseases such as bleeding tendency and coagulation dysfunction.
- Willingly participate in the investigation and study.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The group using the whole-breast bandaging methodUse 1 to 2 pieces of sterile loose gauze to knead into a gauze ball, press it on the residual cavity. Then, continue to use 5 to 8 pieces of loose gauze to stack gauze balls within a diameter of 5 cm around the wound for bandaging. Finally, apply compression bandaging with an elastic bra. The time for compression bandaging with the elastic bra is 24 hours. | Procedure or surgery | The group using the whole-breast bandaging method |
| The group using the local bandaging methodKnead 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 just one day. | Procedure or surgery | The group using the local bandaging method |
Primary outcome
The incidence of hematoma in patients: Use breast color Doppler ultrasound to check the wound healing condition and the presence of hematoma
Time frame: At 2 weeks and 3 months after the operation respectively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing The group using the whole-breast bandaging method and The group using the local bandaging method in people with Minimally Invasive Mammary Gland Vacuum-Assisted Biopsy, run by Guangdong Provincial People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of hematoma in patients: Use breast color Doppler ultrasound to check the wound healing condition and the presence of hematoma (time frame: At 2 weeks and 3 months after the operation respectively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.