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

NCT ID: NCT07185334

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-15
• Study Completion Date: 2027-05-15

Brief 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

Detailed 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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Main group

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.

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

For this group of patients, the planned volume of surgical intervention is: subcutaneous mastectomy using a polyester mesh endoprosthesis with a fluoropolymer coating and one-stage prepectoral installation of textured implants.

Control group

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

Group Type: OTHER

Subcutaneous mastectomy with simultaneous prepectoral placement of textured implants.

Intervention Type: PROCEDURE

This group of patients will undergo surgical intervention in deep subcutaneous mastectomy with simultaneous prepectoral placement of textured implants.

Interventions

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

For this group of patients, the planned volume of surgical intervention is: subcutaneous mastectomy using a polyester mesh endoprosthesis with a fluoropolymer coating and one-stage prepectoral installation of textured implants.

Intervention Type: PROCEDURE

Subcutaneous mastectomy with simultaneous prepectoral placement of textured implants.

This group of patients will undergo surgical intervention in deep subcutaneous mastectomy with simultaneous prepectoral placement of textured implants.

Intervention Type: PROCEDURE

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Saint Petersburg State University, Russia

OTHER

Sponsor Role: lead

Responsible Party

Laisan Shaikhelislamova

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Saint Petersburg State University

Saint Petersburg, , Russia

Countries

Russia

Other Identifiers

50

Identifier Type: -

Identifier Source: org_study_id