Skip to content

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07442838
Acronym
RA-IBBR-NvsM
Enrollment
88
Registered
2026-03-02
Start date
2025-06-24
Completion date
2026-04-28
Last updated
2026-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Keywords

Breast Reconstruction, Tissue Expander, Implant-based Reconstruction, Postoperative Complications, Nano-textured Expanders, Micro-textured Expanders

Brief 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.

Interventions

None listed

Sponsors

Comenius University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Association Between Expander Surface Type and ComplicationsUp to 12 months after reconstruction surgeryIncidence of postoperative complications following implant-based breast reconstruction, including seroma, infection, hematoma, capsular contracture, expander rupture, expander rotation, explantation and perception of breast hardness.

Countries

Slovakia

Contacts

STUDY_DIRECTORDrahomír Palenčár, MD, PhD

Faculty of Medicine, Comenius University Bratislava

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026