Clinical trial · Observational
Clinical Outcomes and Complications in Two-stage Breast Reconstruction Using Microtextured and Nanotextured Expanders
Retrospective Analysis of Clinical Outcomes and Complication Rates in Patients Undergoing Two-Stage Breast Reconstruction Using Nano- and Microtextured Tissue Expanders With Evaluation of the Impact of Prior Radiotherapy
- 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)
This retrospective observational study evaluates clinical outcomes and complication rates in women who underwent two-staged implant-based breast reconstruction using tissue expanders and implants following mastectomy for breast cancer. The study focuses on comparing postoperative complications associated with nano- and microtextured tissue expanders and assessing the influence of prior radiotherapy on reconstructive outcomes. The hypothesis of the study is that the surface characteristics of tissue expanders and a history of radiotherapy may influence the incidence and type of postoperative complications as well as overall reconstructive success.
Conditions
Conditions (1)
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (4)
- label
- Nanotextured, post-RT
- description
- Nanotextured, post-RT -group of radiated breast tissue prior to the nanotextured-expander surgery
- label
- Nanotextured, no-RT
- description
- Nanotextured, no-RT - group of not-radiated breast tissue prior to the nanotextured-expander surgery
- label
- Microtextured, post-RT
- description
- Microtextured, post-RT - group of radiated breast tissue prior to the microtextured-expander surgery
- label
- Microtextured, no-RT
- description
- Microtextured, no-RT- group of not-radiated breast tissue prior to the microtextured-expander surgery
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * History of mastectomy for breast cancer or prophylactic mastectomy * Undergoing two-stage breast reconstruction * Reconstruction performed using tissue expanders and implants * Availability of complete medical documentation * Regular follow-up visits Exclusion Criteria: * Reconstruction using autologous tissue * Reconstruction using permanent expander * Single-stage Reconstruction using implant * Incomplete clinical documentation * Missing follow-up data relevant to complication assessment
References
Publications (0)
Data not yet available