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Active, Not Recruiting

NCT Number: NCT07442838

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Bratislava

Bratislava, 82101, Slovakia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Association Between Expander Surface Type and Complications

    Time frame: Up to 12 months after reconstruction surgery

    Incidence of postoperative complications following implant-based breast reconstruction, including seroma, infection, hematoma, capsular contracture, expander rupture, expander rotation, explantation and perception of breast hardness.

Sponsors and collaborators

Lead sponsor

Comenius University

Other

Registry information

Official study title

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

Acronym: RA-IBBR-NvsM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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