Axillary Versus Primary Breast Approach for Second-stage Breast Reconstruction

Not Applicable

Not yet recruiting

• Conditions: Breast Neoplasm Female; Breast Reconstruction; Wound Complication
• Interventions: Procedure: implant exchange operation

• Registration Number: NCT05600153
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-12
• Study First Submitted QC: 2022-10-26
• Last Update Submitted: 2022-10-26
• Study First Posted: 2022-10-31
• Last Update Posted: 2022-10-31
• Study Start: 2022-12
• Primary Completion: 2024-01
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 136

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
primary breast approach	implant exchange operation	-
axillary approach	implant exchange operation	-

Primary Outcome Measures

Name	Time	Method
Proportion of Wound healing within 7 days post-operation	up to 7 days post-operation	Without one of the following conditions：wound dehiscence requiring local wound care or operative intervention, wound infection requiring antibiotics 24hours post-operation, or debridement, within 7 days of post-operation.

Secondary Outcome Measures

Name	Time	Method
Length of incision	up to 7 days post-operation	length of incision measured within one-week post-operation.
other surgical complications	one year	Including hematoma, seroma, nipple and areola Necrosis, implant exposure, implant removal, and cyst contracture, measured by Clavien-Dindo stage.
Breast Q score	one year	The satisfaction of breast reconstruction of participants will be measured by Breast Q questionnaire 12 months post-operation. Breast-Q questionnaire is based on 6 dimensions: Physical health, mental health, sexual health, satisfaction with breast, satisfaction with surgical outcome, and satisfaction with medical care. The scores of each dimension are expressed as independent scores between 0 and 100 calculated by the Q Score system.
Pathological evaluation	through study completion	A piece of scar tissue will be collected during surgery and embedded with paraffin, and pathological evaluation, including Masson staining, immune histochemistry of desmin, SMA, Ki67，TGFβ，Smad2/3，CTGF/CCN2，IL-6, IL-8，MMP-1，MMP-2，MMP-3，MMP-13，COL I，COLIII, COL-5. And the staining intensity will be measured by two independent pathologists.

Trial Locations

Locations (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China; 🇨🇳 Hangzhou, Zhejiang, China