Axillary Versus Primary Breast Approach for Second-stage Breast Reconstruction (AvBSR)

Zhejiang University

Status: Not yet enrolling

Conditions: Breast Reconstruction; Breast Neoplasm Female; Wound Complication

Treatments: Procedure: implant exchange operation

Study type: Interventional

Funder types: Other

Identifiers

NCT05600153

IRB-2022- 1451

Details and patient eligibility

About

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.

Enrollment: 136 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups, including a placebo group

primary breast approach

Placebo Comparator group

Treatment:

Procedure: implant exchange operation

axillary approach

Experimental group

Treatment:

Procedure: implant exchange operation