Clinical trial Recruiting at 1 site Interventional Ages 18 and up Women only

Using PTFE mesh for breast reconstruction in cancer patients

Official title: Ways of Retaining the Inframammary Fold in Implant-based Breast Surgery Using Polytetrafluoroethylene (PTFE) Mesh or Allogeneic Dura Mater Graft

Run by Branch Office of "Hadassah Medical Ltd" · NCT06931548 · Data updated 2026-11-12

This study tests if using a special mesh called PTFE can help women with early-stage breast cancer have better and safer breast reconstruction compared to a traditional method.

Quick facts

Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment100 (estimated)
SponsorBranch Office of "Hadassah Medical Ltd"
Academic / other
Locations1 site (Moscow, Skolkovo Innovation Center)
StatusRecruiting
StartedMarch 1, 2022
Main results expectedAugust 2025
Study endsFebruary 2026
Registry record updatedApril 17, 2025
Trial IDNCT06931548 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are white women diagnosed with breast cancer stages 0 to II who require breast reconstruction.

Probably not a fit

Patients with advanced breast cancer (stages III-IV), non-white women, or those with specific health conditions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the use of polytetrafluoroethylene (PTFE) mesh in implant-based breast reconstruction for women diagnosed with early-stage breast cancer. It compares the efficacy and safety of PTFE mesh against allogeneic dura mater grafts, both of which are used to support breast implants. The study aims to determine if PTFE mesh can provide better outcomes in terms of complications and aesthetic results compared to traditional methods. Participants will be white women with breast cancer stages 0 to II who consent to the study and photographic documentation.

Why it matters

Potential benefit: If successful, this approach could lead to improved safety and aesthetic outcomes in breast reconstruction for cancer patients.

How similar studies have gone: Previous studies have shown promising results with synthetic meshes in other surgical fields, suggesting potential for success in this application.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* White women;
* Breast cancer stage 0-II;
* Indications for breast reconstruction;
* Consent to participate in the study and photographic documentation.

Exclusion Criteria:

* Non-white women;
* Breast cancer stage III-IV;
* Tubular breast;
* Mental and cognitive health disorders;
* Failure to comply with recommendations in the postoperative period (premature physical activity, not wearing compression underwear, missing scheduled visits, refusal of photo documentation);
* Patient refusal to participate in the study at any stage.

Where it's running

  • The Branch of Hadassah Medical LTD
    Moscow, Skolkovo Innovation Center, Russia
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.