Back to resultsAxillary Versus Primary Breast Approach for Second-stage Breast Reconstruction (AvBSR)
Primary Purpose
Breast Neoplasm Female, Breast Reconstruction, Wound Complication
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
implant exchange operation
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasm Female
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)
Sites / Locations
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
primary breast approach
axillary approach
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
other surgical complications
Including hematoma, seroma, nipple and areola Necrosis, implant exposure, implant removal, and cyst contracture, measured by Clavien-Dindo stage.
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.
Length of incision
length of incision measured within one-week post-operation.
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，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.
Full Information
NCT ID
NCT05600153
First Posted
October 12, 2022
Last Updated
October 26, 2022
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Affiliated Hangzhou First People's Hospital, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT05600153
Brief Title
Axillary Versus Primary Breast Approach for Second-stage Breast Reconstruction
Acronym
AvBSR
Official Title
Axillary Versus Primary Breast Approach for Second-stage Operation in Expander-Implant Breast Reconstruction
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Affiliated Hangzhou First People's Hospital, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm Female, Breast Reconstruction, Wound Complication
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
primary breast approach
Arm Type
Placebo Comparator
Arm Title
axillary approach
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
implant exchange operation
Intervention Description
To perform implant exchange via axillary incision.
Primary Outcome Measure Information:
Title
Proportion of Wound healing within 7 days post-operation
Description
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.
Time Frame
up to 7 days post-operation
Secondary Outcome Measure Information:
Title
other surgical complications
Description
Including hematoma, seroma, nipple and areola Necrosis, implant exposure, implant removal, and cyst contracture, measured by Clavien-Dindo stage.
Time Frame
one year
Title
Breast Q score
Description
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.
Time Frame
one year
Title
Length of incision
Description
length of incision measured within one-week post-operation.
Time Frame
up to 7 days post-operation
Title
Pathological evaluation
Description
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.
Time Frame
through study completion
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chao NI
Phone
+8613989463951
Email
nicaho428@zju.edu.cn
Facility Information:
Facility Name
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
City
Hangzhou
State/Province
Zhejiang
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Anyone needs individual participant data should contact the main investigator via e-mail.
Learn more about this trial
Axillary Versus Primary Breast Approach for Second-stage Breast Reconstruction
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