Axillary Versus Primary Breast Approach for Second-stage Breast Reconstruction

Breast Reconstruction Clinical Trial

— AvBSR  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05600153
• Other study ID #: IRB-2022- 1451
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2022
• Est. completion date: December 2024

Study information

• Verified date: October 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Chao NI
• Phone: +8613989463951
• Email: nicaho428[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 136
• Est. completion date: December 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Neoplasm Female
• Breast Neoplasms
• Breast Reconstruction
• Wound Complication

Intervention

Procedure:
• implant exchange operation
To perform implant exchange via axillary incision.

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University, China	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Affiliated Hangzhou First People's Hospital, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Wound healing within 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.	up to 7 days post-operation
Secondary	other surgical complications	Including hematoma, seroma, nipple and areola Necrosis, implant exposure, implant removal, and cyst contracture, measured by Clavien-Dindo stage.	one year
Secondary	Breast Q score	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.	one year
Secondary	Length of incision	length of incision measured within one-week post-operation.	up to 7 days post-operation
Secondary	Pathological evaluation	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,TGFß,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.	through study completion