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| Name | Class |
|---|---|
| Affiliated Hangzhou First People's Hospital, Zhejiang University | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| primary breast approach | Placebo Comparator |
| |
| axillary approach | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| implant exchange operation | Procedure | To perform implant exchange via axillary incision. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 7 days post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| other surgical complications | Including hematoma, seroma, nipple and areola Necrosis, implant exposure, implant removal, and cyst contracture, measured by Clavien-Dindo stage. | one year |
| Breast Q score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chao NI | Contact | +8613989463951 | nicaho428@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China | Hangzhou | Zhejiang | China |
Anyone needs individual participant data should contact the main investigator via e-mail.
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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.
| one year |
| Length of incision | length of incision measured within one-week post-operation. | 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. | through study completion |