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

NCT07442838 | Active Not Recruiting

• 1 other identifier: RA-IBBR-NvsM
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Association Between Expander Surface Type and Complications

  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

Study Arms (4)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Reconstruction using autologous tissue
• Reconstruction using permanent expander
• Single-stage Reconstruction using implant
• Incomplete clinical documentation
• Missing follow-up data relevant to complication assessment

Sponsors & Collaborators

• Comenius University: lead

Study Sites (1)

University Hospital Bratislava

Bratislava, 82101, Slovakia

Location

MeSH Terms

Conditions

Breast Neoplasms; Postoperative Complications

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Drahomír Palenčár, MD, PhD

  Faculty of Medicine, Comenius University Bratislava

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 2, 2026
• Study Start: June 24, 2025
• Primary Completion: February 2, 2026
• Study Completion: April 28, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)