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Axillary Versus Primary Breast Approach for Second-stage Operation in Expander-Implant Breast Reconstruction
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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, China
Start Date
December 1, 2022
Primary Completion Date
January 1, 2024
Completion Date
December 1, 2024
Last Updated
October 31, 2022
136
ESTIMATED participants
implant exchange operation
PROCEDURE
Lead Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
NCT07465523
NCT03175718
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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