Clinical Outcomes and Complications in Two-stage Breast Reconstruction Using Microtextured and Nanotextured Expanders (RA-IBBR-NvsM)

March 1, 2026 updated by: Comenius University

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.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Actual)

88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovakia
      • Bratislava, Slovakia, 82101
        • University Hospital Bratislava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women undergoing two-stage implant based breast reconstruction following mastectomy for breast cancer or as prophylactics at a tertiary care center National Cancer Institute in Bratislava.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Nanotextured, post-RT
Nanotextured, post-RT -group of radiated breast tissue prior to the nanotextured-expander surgery
Nanotextured, no-RT
Nanotextured, no-RT - group of not-radiated breast tissue prior to the nanotextured-expander surgery
Microtextured, post-RT
Microtextured, post-RT - group of radiated breast tissue prior to the microtextured-expander surgery
Microtextured, no-RT
Microtextured, no-RT- group of not-radiated breast tissue prior to the microtextured-expander surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 12 months after reconstruction surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Comenius University

Investigators

  • Study Director: Drahomír Palenčár, MD, PhD, Faculty of Medicine, Comenius University Bratislava

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2025

Primary Completion (Actual)

February 2, 2026

Study Completion (Estimated)

April 28, 2026

Study Registration Dates

First Submitted

February 24, 2026

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

March 1, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA-IBBR-NvsM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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