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Trial Title:
Axillary Versus Primary Breast Approach for Second-stage Breast Reconstruction
NCT ID:
NCT05600153
Condition:
Breast Neoplasm Female
Breast Reconstruction
Wound Complication
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
implant exchange operation
Description:
To perform implant exchange via axillary incision.
Arm group label:
axillary approach
Arm group label:
primary breast approach
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.
Criteria for 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)
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Address:
City:
Hangzhou
Country:
China
Start date:
December 2022
Completion date:
December 2024
Lead sponsor:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Collaborator:
Agency:
Affiliated Hangzhou First People's Hospital, Zhejiang University
Agency class:
Other
Source:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05600153
