AvBSR: Axillary Versus Primary Breast Approach for Second-stage Breast Reconstruction

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05600153
• Collaborator: Affiliated Hangzhou First People's Hospital, Zhejiang University (Other)
• Enrollment: 136
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 5.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasm Female; Breast Reconstruction; Wound Complication	Procedure: implant exchange operation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 136 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Axillary Versus Primary Breast Approach for Second-stage Operation in Expander-Implant Breast Reconstruction
• Anticipated Study Start Date: Dec 1, 2022
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: primary breast approach	Procedure: implant exchange operation; To perform implant exchange via axillary incision.
Experimental: axillary approach	Procedure: implant exchange operation; To perform implant exchange via axillary incision.

Outcome Measures

Primary Outcome Measures

1. 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

1. other surgical complications [one year]

   Including hematoma, seroma, nipple and areola Necrosis, implant exposure, implant removal, and cyst contracture, measured by Clavien-Dindo stage.

2. 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.

3. Length of incision [up to 7 days post-operation]

   length of incision measured within one-week post-operation.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	2nd Affiliated Hospital, School of Medicine, Zhejiang University, China	Hangzhou	Zhejiang	China

Sponsors and Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University
• Affiliated Hangzhou First People's Hospital, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
• ClinicalTrials.gov Identifier: NCT05600153
• Other Study ID Numbers: IRB-2022- 1451
• First Posted: Oct 31, 2022
• Last Update Posted: Oct 31, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Oct 31, 2022