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Not Yet Recruiting NCT05600153

Axillary Versus Primary Breast Approach for Second-stage Breast Reconstruction

Conditions: Breast Neoplasm Female, Breast Reconstruction, Wound Complication

Sex: Female
Ages: 18 Years – N/A
Phase: NA
Enrollment: 136
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Location: China

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)FemaleInvasive breast cancer or ductal carcinoma in situ was confirmed by preoperative pathologySSM/NSM (skin sparing/nipple and areola sparing mastectomy) combined with expander implantation has been performed within a yearAn incision on the surface of the breast is used to place an expander in the first-stage surgeryThere is no clinical or radiological evidence of distant metastasisExpander removal combined with prosthesis implantation is plannedAble and willing to sign an informed consentExclusion Criteria:The first SSM/NSM combined expander implantation was performed via axillary approachPatients participate in other clinical trial, which could potentially affect their participation in this trialAdjuvant radiotherapy was planned post-operationPatient who is pregnant and lactatingThe expander is not sufficiently expanded pre-surgery (does not reach more than 90% of its volume)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05600153). StuddyBuddy aggregates publicly available trial information.