Breast Neoplasm Female, Breast Reconstruction, Wound Complication
Conditions
Brief 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. 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.
Interventions
PROCEDUREimplant exchange operation
To perform implant exchange via axillary incision.
Sponsors
Affiliated Hangzhou First People's Hospital, Zhejiang University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Wound healing within 7 days post-operation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| other surgical complications | one year | Including hematoma, seroma, nipple and areola Necrosis, implant exposure, implant removal, and cyst contracture, measured by Clavien-Dindo stage. |
| Breast Q score | one year | 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. |
| Length of incision | up to 7 days post-operation | length of incision measured within one-week post-operation. |
| Pathological evaluation | through study completion | 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. |
Countries
China
Contacts
Primary ContactChao NI
Outcome results
None listed