Active — Not RecruitingNot Applicable

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

Slovakia88 participantsStarted 2025-06-24

Plain-language 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.

Who can participate

SexALL

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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

What they're measuring

Association Between Expander Surface Type and Complications

Timeframe: Up to 12 months after reconstruction surgery

Trial details

NCT IDNCT07442838

SponsorComenius University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-02-02

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