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New coated mesh aims to stop implants from poking through skin

NCT ID NCT07185334

Disease control Sponsor: Saint Petersburg State University, Russia 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether a polyester mesh coated with fluoropolymer can reduce complications after breast reconstruction in women with breast cancer. One hundred women will receive either standard reconstruction or reconstruction with the coated mesh. The main goal is to see if the mesh lowers the chance of the implant pushing through the skin.

What this could mean

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

Active substance
polyester mesh with fluoropolymer coating
What this could lead to
If successful, this mesh could lower the risk of implant protrusion and other complications after breast reconstruction.
What could go wrong
This is a small, early-stage study without a control group, so results may not apply broadly. The mesh could still cause seroma or capsular contracture.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

May 2027

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.

Ages

18 years and older

Sex

Female participants only

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: 1. Women with a verified breast cancer diagnosis over 18 years of age; 2. ECOG 0-1; 3. Stage: clinical T1, T2 or T3, N0-3, M0; 4. The thickness of subcutaneous adipose tissue (Pinch Test) is more than 5 mm 5. Signed informed voluntary consent. Exclusion Criteria: 1. Women under 18 years of age; 2. ECOG 2-4; 3. Stage: clinical T4, M1; 4. The thickness of subcutaneous adipose tissue (Pinch Test) is less than 5 mm; 5. Intolerance and / or allergic reaction to the mesh endoprosthesis, implant and/or its component;

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm metabolic dysfunction-associated steatohepatitis

As listed by the trial registrant

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

Breast cancer Breast reconstruction Coated materials Mash with fibrosis Reconstruction breast surgery

Contacts and locations

Locations

  • Saint Petersburg State University

    Saint Petersburg, Russia

More trials for these conditions

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