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New study compares nano vs microtextured expanders in breast reconstruction

NCT ID NCT07442838

Knowledge-focused Sponsor: Comenius University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks back at 88 women who had two-stage breast reconstruction after mastectomy for breast cancer. It compares complication rates between nano- and microtextured tissue expanders and checks how prior radiotherapy affects outcomes. The goal is to find which expander type may lead to fewer problems like infection or capsular contracture.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors choose better tissue expanders and plan safer breast reconstruction for women who have had radiotherapy.
What could go wrong
This is a small, retrospective observational study, so it cannot prove cause and effect. Results may not apply to all patients or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

88 people

The number who actually took part.

Started

Jun 2025

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Postoperative Complications

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast neoplasms

Contacts and locations

Locations

  • University Hospital Bratislava

    Bratislava, 82101, Slovakia

More trials for these conditions

Other studies related to the condition(s) this trial covers.