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

Saint Petersburg State University, Russia

Status: Active, not recruiting

Conditions: Reconstruction Breast Surgery; Breast Reconstruction; Breast Cancer; MASH With Fibrosis; Coated Materials

Treatments: Procedure: Subcutaneous mastectomy with simultaneous prepectoral placement of textured implants.; Procedure: Subcutaneous mastectomy using a fluoropolymer-coated polyester mesh endoprosthesis with simultaneous prepectoral placement of textured implants.

Study type: Interventional

Funder types: Other

Identifiers

NCT07185334

50

Details and patient eligibility

About

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

Full description

The study includes female patients aged 18 and above with a verified breast cancer diagnosis, ECOG performance status 0-1, and clinical stage T1-T3, N0-3, M0, who provide informed consent. Exclusion criteria involve intolerance or allergic reactions to mesh endoprostheses or implants and a subcutaneous adipose tissue thickness of less than 5 mm (measured via Pinch Test). Participants will be non-randomly allocated into two groups: the main group, receiving a polyester mesh endoprosthesis with fluoropolymer coating alongside textured implants, and the control group, receiving textured implants alone. Surgical procedures will involve subcutaneous mastectomy with implant placement based on preoperative measurements of breast dimensions, with or without nipple-areolar complex preservation. Postoperative follow-ups at 1, 3-6, and 9-12 months will assess complications such as protrusions, seromas, implant contouring (rippling), capsular contracture, and dystopia via physical examination and ultrasound. The hypothesis posits that the use of mesh endoprostheses will lower protrusion rates compared to standard implant placement, offering a potential advancement in reducing postoperative risks in breast reconstruction for breast cancer patients.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Main group

Experimental group

Description:

The main group will consist of patients with the planned volume of surgical intervention: subcutaneous mastectomy using a polyester mesh endoprosthesis with a fluoropolymer coating and simultaneous prepectoral placement of textured implants.

Treatment:

Procedure: Subcutaneous mastectomy using a fluoropolymer-coated polyester mesh endoprosthesis with simultaneous prepectoral placement of textured implants.

Control group

Other group

Description:

The control group will consist of patients who undergo surgical treatment for subcutaneous mastectomy, with simultaneous placement of textured breast implants with no polyester mesh endoprosthesis with a fluoropolymer coating

Treatment:

Procedure: Subcutaneous mastectomy with simultaneous prepectoral placement of textured implants.