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

NCT07185334 | Active Not Recruiting DMC

• 1 other identifier: 50
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Fluoropolymer coated mesh; Implant-based reconstruction in breast cancer patients

Outcome Measures

Primary Outcomes (1)

• Frequency of protrusions throughout the year

  Implant protrusion is a complication that occurs after reconstructive plastic surgery. In this type of surgery, the implant is displaced from its anatomically correct position leading to its protrusion through the skin. This happens when the integrity or strength of the tissues that hold the implant (such as capsules, muscles, and fascia) is compromised.

  1 year

Secondary Outcomes (1)

• 1. Frequency of seroma 2. Frequency of Rippling 3. Frequency of Capsular contracture 4. Frequency of Dystopia

  1 year

Study Arms (2)

Main group

EXPERIMENTAL

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.

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

Control group

OTHER

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

Procedure: 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. 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.

Main group

Subcutaneous mastectomy with simultaneous prepectoral placement of textured implants. PROCEDURE

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Saint Petersburg State University, Russia: lead

Study Sites (1)

Saint Petersburg State University

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy, Subcutaneous

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Main group- The main group will consist of patients undergoing surgical treatment for subcutaneous mastectomy using a polyester mesh endoprosthesis with a fluoropolymer coating, with simultaneous prepectoral placement 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.

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 22, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)