Clinical trial · Interventional
Axillary Versus Primary Breast Approach for Second-stage Breast Reconstruction
Axillary Versus Primary Breast Approach for Second-stage Operation in Expander-Implant Breast Reconstruction
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasm Female | — | UNRESOLVED | — |
| Breast Reconstruction | — | UNRESOLVED | — |
| Wound Complication | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| implant exchange operation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- primary breast approach
- interventionNames
- Procedure: implant exchange operation
- type
- EXPERIMENTAL
- label
- axillary approach
- interventionNames
- Procedure: implant exchange operation
Primary outcomes (1)
- measure
- Proportion of Wound healing within 7 days post-operation
- timeFrame
- up to 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.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available