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

NCT07185334 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-09-22

No results posted yet for this study

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

Interventions

PROCEDURE

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.

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.

Sponsors & Collaborators

  • Saint Petersburg State University, Russia

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-15
Primary Completion
2026-05-15
Completion
2027-05-15

Countries

  • Russia

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07185334 on ClinicalTrials.gov