Breast Neoplasm FemaleAvBSRNCT05600153
Axillary Versus Primary Breast Approach for Second-stage Breast Reconstruction
A study testing implant exchange operation in people with Breast Neoplasm Female and Breast Reconstruction, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this clinical trial is to compare the safety of axillary or primary breast approach for second-stage operation in expander-implant breast reconstruction for breast cancer patients. The main question it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm Female, Breast Reconstruction, Wound Complication
- What is being tested?
- implant exchange operation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- Dec 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 + (inclusive)
- Female
- Invasive breast cancer or ductal carcinoma in situ was confirmed by preoperative pathology
- SSM/NSM (skin sparing/nipple and areola sparing mastectomy) combined with expander implantation has been performed within a year
- An incision on the surface of the breast is used to place an expander in the first-stage surgery
- There is no clinical or radiological evidence of distant metastasis
- Expander removal combined with prosthesis implantation is planned
- Able and willing to sign an informed consent
Who cannot join
- The first SSM/NSM combined expander implantation was performed via axillary approach
- Patients participate in other clinical trial, which could potentially affect their participation in this trial
- Adjuvant radiotherapy was planned post-operation
- Patient who is pregnant and lactating
- The expander is not sufficiently expanded pre-surgery (does not reach more than 90% of its volume)
Trial locations and contacts
1 site in 1 country.
China1 site
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang
About this study
Official title: Axillary Versus Primary Breast Approach for Second-stage Operation in Expander-Implant Breast Reconstruction
The goal of this clinical trial is to compare the safety of axillary or primary breast approach for second-stage operation in expander-implant breast reconstruction for breast cancer patients. The main question it aims to answer are: 1. if the wound related events, including wound dehiscence, infection, delayed healing is significant less often in patients receiving second stage operation via axillary approach compared with primary breast approach; 2. if the aesthetic outcome is comparable between patients receiving different approach for second stage operation. To answer these questions, the breast cancer patients have received nipple-sparing or skin-sparing mastectomy and had breast tissue expander insertion via breast incision, will be prospectively recruited, and randomized into two groups while receiving implant exchange operation: (1) operate via axillary incision; (2) operate via primary breast incision.
- Being tested
- implant exchange operation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant exchange operationProcedure or surgery
To perform implant exchange via axillary incision.
| Study group | Role | What they receive |
|---|---|---|
| primary breast approach | Placebo comparator | Not described Receives: Procedure: implant exchange operation |
| axillary approach | Experimental | Not described Receives: Procedure: implant exchange operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Wound healing within 7 days post-operation
Without one of the following conditions：wound dehiscence requiring local wound care or operative intervention, wound infection requiring antibiotics 24hours post-operation, or debridement, within 7 days of post-operation.
Measured: up to 7 days post-operation
Secondary outcomes (4)
other surgical complications
Including hematoma, seroma, nipple and areola Necrosis, implant exposure, implant removal, and cyst contracture, measured by Clavien-Dindo stage.
Measured: one year
Breast Q score
The satisfaction of breast reconstruction of participants will be measured by Breast Q questionnaire 12 months post-operation. Breast-Q questionnaire is based on 6 dimensions: Physical health, mental health, sexual health, satisfaction with breast, satisfaction with surgical outcome, and satisfaction with medical care. The scores of each dimension are expressed as independent scores between 0 and 100 calculated by the Q Score system.
Measured: one year
Length of incision
length of incision measured within one-week post-operation.
Measured: up to 7 days post-operation
Pathological evaluation
A piece of scar tissue will be collected during surgery and embedded with paraffin, and pathological evaluation, including Masson staining, immune histochemistry of desmin, SMA, Ki67，TGFβ，Smad2/3，CTGF/CCN2，IL-6, IL-8，MMP-1，MMP-2，MMP-3，MMP-13，COL I，COLIII, COL-5. And the staining intensity will be measured by two independent pathologists.
Measured: through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study startDec 2022 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Neoplasm FemaleStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600153
- Sponsor's protocol ID
- IRB-2022- 1451
- Acronym
- AvBSR
- Status last verified
- Oct 2022
- First submitted
- 12 Oct 2022
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anyone needs individual participant data should contact the main investigator via e-mail.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Axillary Versus Primary Breast Approach for Second-stage Operation in Expander-Implant Breast Reconstruction
- ClinicalTrials.gov ID
- NCT05600153
- Acronym / sponsor ID
- AvBSR / IRB-2022- 1451
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University
- Study start
- Dec 2022 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 31 Oct 2022 (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.
The goal of this clinical trial is to compare the safety of axillary or primary breast approach for second-stage operation in expander-implant breast reconstruction for breast cancer patients. The main question it aims to answer are: 1. if the wound related events, including wound dehiscence, infection, delayed healing is significant less often in patients receiving second stage operation via axillary approach compared with primary breast approach; 2. if the aesthetic outcome is comparable between patients receiving different approach for second stage operation. To answer these questions, the breast cancer patients have received nipple-sparing or skin-sparing mastectomy and had breast tissue expander insertion via breast incision, will be prospectively recruited, and randomized into two groups while receiving implant exchange operation: (1) operate via axillary incision; (2) operate via primary breast incision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| primary breast approach | Placebo comparator | Procedure: implant exchange operation |
| axillary approach | Experimental | Procedure: implant exchange operation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 + (inclusive)
- Female
- Invasive breast cancer or ductal carcinoma in situ was confirmed by preoperative pathology
- SSM/NSM (skin sparing/nipple and areola sparing mastectomy) combined with expander implantation has been performed within a year
- An incision on the surface of the breast is used to place an expander in the first-stage surgery
Key exclusion criteria (5 listed)
- The first SSM/NSM combined expander implantation was performed via axillary approach
- Patients participate in other clinical trial, which could potentially affect their participation in this trial
- Adjuvant radiotherapy was planned post-operation
- Patient who is pregnant and lactating
- The expander is not sufficiently expanded pre-surgery (does not reach more than 90% of its volume)
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 |
|---|---|---|
| implant exchange operationTo perform implant exchange via axillary incision. | Procedure or surgery | axillary approach, primary breast approach |
Primary outcome
Proportion of Wound healing within 7 days post-operation
Time frame: up to 7 days post-operation
Without one of the following conditions：wound dehiscence requiring local wound care or operative intervention, wound infection requiring antibiotics 24hours post-operation, or debridement, within 7 days of post-operation.
4 secondary outcomes
other surgical complications
Time frame: one year
Breast Q score
Time frame: one year
Length of incision
Time frame: up to 7 days post-operation
Pathological evaluation
Time frame: through study completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Individual participant dataSharing planned: No. Anyone needs individual participant data should contact the main investigator via e-mail.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing implant exchange operation in people with Breast Neoplasm Female and Breast Reconstruction, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chao NI (+8613989463951, nicaho428@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Wound healing within 7 days post-operation (time frame: up to 7 days post-operation). 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 31 Oct 2022.