Axillary Versus Primary Breast Approach for Second-stage Breast Reconstruction

NCT ID: NCT05600153

Last Updated: 2022-10-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-31
• Study Completion Date: 2024-12-31

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.

Conditions

Breast Neoplasm Female; Breast Reconstruction; Wound Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

primary breast approach

Group Type: PLACEBO_COMPARATOR

implant exchange operation

Intervention Type: PROCEDURE

To perform implant exchange via axillary incision.

axillary approach

Group Type: EXPERIMENTAL

implant exchange operation

Intervention Type: PROCEDURE

To perform implant exchange via axillary incision.

Interventions

implant exchange operation

To perform implant exchange via axillary incision.

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hangzhou First People's Hospital, Zhejiang University

UNKNOWN

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

Chao NI

Role: CONTACT

nicaho428@zju.edu.cn

+8613989463951

Other Identifiers

IRB-2022- 1451

Identifier Type: -

Identifier Source: org_study_id