Axillary Versus Primary Breast Approach for Second-stage Breast Reconstruction

Second Affiliated Hospital, School of Medicine, Zhejiang University136 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

136

Conditions

Breast Neoplasm Female Breast Reconstruction Wound Complication

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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.

Time frame: up to 7 days post-operation

Secondary Outcomes

other surgical complications

Including hematoma, seroma, nipple and areola Necrosis, implant exposure, implant removal, and cyst contracture, measured by Clavien-Dindo stage.

Time frame: 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.

Time frame: one year

Length of incision

length of incision measured within one-week post-operation.

Time frame: 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.

Time frame: through study completion