NCT05600153

Axillary Versus Primary Breast Approach for Second-stage Breast Reconstruction

Axillary Versus Primary Breast Approach for Second-stage Operation in Expander-Implant Breast Reconstruction

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Neoplasm Female
• Breast Reconstruction
• Wound Complication

Interventions

Type	Name	Description
PROCEDURE	implant exchange operation	To perform implant exchange via axillary incision.

Timeline

• Start date: 2022-12-01
• Primary completion: 2024-01-01
• Completion: 2024-12-01
• First posted: 2022-10-31
• Last updated: 2022-10-31

Locations

1 site across 1 country: China