Clinical Trial

Clinical Outcomes and Complications in Two-stage Breast Reconstruction Using Microtextured and Nanotextured Expanders

Study acronym: RA-IBBR-NvsM
Active, Not Recruiting
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-02-24.
Trial Details
NCT Number NCT07442838
Lead Sponsor Comenius University
Conditions Breast Neoplasms
Enrollment 88 participants
Start Date 2025-06-24
Primary Completion 2026-02-02 (estimated)
Study Completion 2026-04-28 (estimated)
Updated on ClinicalTrials.gov 2026-03-03