Clinical trial NCT05600153: Axillary Versus Primary Breast Approach for Second-stage Breast Reconstruction
Official title: Axillary Versus Primary Breast Approach for Second-stage Operation in Expander-Implant Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Neoplasm Female
Breast Reconstruction
Wound Complication
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Affiliated Hangzhou First People's Hospital, Zhejiang University
First posted: 2022-10-31
Enrollment: 136
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Proportion of Wound healing within 7 days post-operation
timeFrame: up to 7 days post-operation
Secondary outcomes:
measure: other surgical complications
timeFrame: one year
measure: Breast Q score
timeFrame: one year
measure: Length of incision
timeFrame: up to 7 days post-operation
measure: Pathological evaluation
timeFrame: through study completion
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
state: Zhejiang
Study officials:
References: