Axillary Versus Primary Breast Approach for Second-stage Breast Reconstruction

Study Overview
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Brief Summary
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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.

Official Title
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Axillary Versus Primary Breast Approach for Second-stage Operation in Expander-Implant Breast Reconstruction

Conditions
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Breast Neoplasm Female, Breast Reconstruction, Wound Complication

Intervention / Treatment
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* Procedure: implant exchange operation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: primary breast approach<br> | Procedure: implant exchange operation<br>* To perform implant exchange via axillary incision.<br>|
| Experimental: axillary approach<br> | Procedure: implant exchange operation<br>* To perform implant exchange via axillary incision.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |