NCT07442838

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 88 (actual)
• Sponsor: Comenius University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Breast Neoplasms

Timeline

• Start date: 2025-06-24
• Primary completion: 2026-02-02
• Completion: 2026-04-28
• First posted: 2026-03-02
• Last updated: 2026-03-03

Locations

1 site across 1 country: Slovakia