Using PTFE mesh for breast reconstruction in cancer patients
Ways of Retaining the Inframammary Fold in Implant-based Breast Surgery Using Polytetrafluoroethylene (PTFE) Mesh or Allogeneic Dura Mater Graft
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Branch Office of "Hadassah Medical Ltd" Academic / other |
| Locations | 1 site (Moscow, Skolkovo Innovation Center) |
| Trial ID | NCT06931548 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are white women diagnosed with breast cancer stages 0 to II who require breast reconstruction.
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.
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 performed: Previous studies have shown promising results with synthetic meshes in other surgical fields, suggesting potential for success in this application.
Eligibility criteria
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 this trial is running
Moscow, Skolkovo Innovation Center
- The Branch of Hadassah Medical LTD — Moscow, Skolkovo Innovation Center, Russia (Recruiting)
Study contacts
- Principal investigator: Alla Kartasheva, PhD — The Branch of Hadassah Medical LTD
- Study coordinator: Artem Mishin, MD
- Email: dr.mishin@mail.ru
- Phone: +7 (910) 175-98-75
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.