Breast NeoplasmsRA-IBBR-NvsMNCT07442838
Clinical Outcomes and Complications in Two-stage Breast Reconstruction Using Microtextured and Nanotextured Expanders
An observational study of Breast Neoplasms, run by Comenius University at 1 site in Slovakia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Neoplasms
- How many people
- 88 participants
- Where
- 1 siteSlovakia
- Study dates
- 24 Jun 2025to 28 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Reconstruction using autologous tissue
- Reconstruction using permanent expander
- Single-stage Reconstruction using implant
- Incomplete clinical documentation
- Missing follow-up data relevant to complication assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- Breast Neoplasms
- Keywords
- Breast Reconstruction, Tissue Expander, Implant-based Reconstruction, Postoperative Complications, Nano-textured Expanders, Micro-textured Expanders
- Medical subject headings
- Breast Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 months after reconstruction surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start24 Jun 2025
- Primary completion2 Feb 2026
- Study completion28 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Comenius University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Drahomír Palenčár, MD, PhD, Study director, Faculty of Medicine, Comenius University Bratislava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442838
- Sponsor's protocol ID
- RA-IBBR-NvsM
- Acronym
- RA-IBBR-NvsM
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07442838
- Acronym / sponsor ID
- RA-IBBR-NvsM / RA-IBBR-NvsM
- Conditions
- Breast Neoplasms
- Keywords
- Breast Reconstruction, Tissue Expander, Implant-based Reconstruction, Postoperative Complications, Nano-textured Expanders, Micro-textured Expanders
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Comenius UniversityUniversity, hospital or other
- Study start
- 24 Jun 2025 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- 28 Apr 2026 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Reconstruction using autologous tissue
- Reconstruction using permanent expander
- Single-stage Reconstruction using implant
- Incomplete clinical documentation
- Missing follow-up data relevant to complication assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Drahomír Palenčár, MD, PhD study director
Faculty of Medicine, Comenius University Bratislava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by Comenius University at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association Between Expander Surface Type and Complications (time frame: Up to 12 months after reconstruction surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.