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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
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.
Breast reconstruction represents an integral component of comprehensive breast cancer management, contributing significantly to the physical and psychological well-being of patients following mastectomy. Implant-based two-stage breast reconstruction using tissue expanders remains one of the most commonly performed reconstructive techniques. This retrospective cohort study analyzes clinical data from women who underwent two stage breast reconstruction with the use of tissue expanders. The primary objective is to evaluate surgical outcomes and complication rates associated with different expander surface characteristics, specifically nano- and microtextured expanders. Particular attention is given to postoperative complications, including seroma formation, infection, hematoma, capsular contracture, expander rupture, expander rotation, explantation, and subjective perception of breast hardness. Additionally, the study assesses the impact of prior radiotherapy on complication rates and reconstructive outcomes. The study aims to contribute to the optimisation of reconstructive strategies and expander selection by identifying potential associations between expander surface type, radiotherapy exposure, and clinical outcomes.
Age
All ages
Sex
ALL
Healthy Volunteers
No
University Hospital Bratislava
Bratislava, Slovakia
Start Date
June 24, 2025
Primary Completion Date
February 2, 2026
Completion Date
April 28, 2026
Last Updated
March 3, 2026
88
ACTUAL participants
Lead Sponsor
Comenius University
NCT07191730
NCT06312176
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06797635