Active — Not RecruitingNot Applicable

Single-Stage Prepectoral Placement of Textured Implants Using a Polyester Mesh Endoprostheses With Fluoropolymer Coating in Patients With Breast Cancer

Russia100 participantsStarted 2025-05-15

Plain-language summary

This study aims to evaluate the efficacy of using a polyester mesh endoprosthesis with a fluoropolymer coating in reducing postoperative complications, particularly protrusions, following subcutaneous mastectomy with simultaneous prepectoral placement of textured breast implants in women with breast cancer

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. Women with a verified breast cancer diagnosis over 18 years of age;
✓. ECOG 0-1;
✓. Stage: clinical T1, T2 or T3, N0-3, M0;
✓. The thickness of subcutaneous adipose tissue (Pinch Test) is more than 5 mm
✓. Signed informed voluntary consent.

Exclusion criteria

✕. Women under 18 years of age;
✕. ECOG 2-4;
✕. Stage: clinical T4, M1;
✕. The thickness of subcutaneous adipose tissue (Pinch Test) is less than 5 mm;
✕. Intolerance and / or allergic reaction to the mesh endoprosthesis, implant and/or its component;

What they're measuring

Frequency of protrusions throughout the year

Timeframe: 1 year

Trial details

NCT IDNCT07185334

SponsorSaint Petersburg State University, Russia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-15

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