Ways of Retaining the Inframammary Fold in Implant-based Breast Surgery

Summary

There is currently no consensus on the "gold standard" for Implant-based Breast reconstruction. In the United States, more than half of all breast reconstructions are performed using acellular dermal matrix (ADM). However, based on the findings of literature and systematic reviews, it can be cautiously said that synthetic meshes cause fewer complications with comparable aesthetic results and low cost. In our study, we propose using polytetrafluoroethylene (PTFE) mesh in implant-based breast reconstruction. This material has previously proven itself in cardiovascular, maxillofacial and neurosurgery, hernioplasty and as a suture material. Allogeneic dura mater, which has demonstrated comparable results in breast reconstruction with the literature, will be used as a comparison. The purpose of this study is to evaluate the efficacy and safety of a porous, non-biodegradable, synthetic polytetrafluoroethylene mesh for implant-based breast reconstruction in patients diagnosed with breast cancer. An allogeneic dura mater technique will be used as a control.

Patients eligible for this study are classified according to the National Comprehensive Cancer Network (NCCN) guidelines as having stage 0-2 breast cancer.

The primary questions this study aims to answer are:

* What are the rates of major and minor complications associated with these techniques. Major complications will be defined as complications leading to reoperation.
* How effective are PTFE mesh and dura in maintaining the inframammary fold and implant projection after breast reconstruction?
* What is the patient satisfaction rate with the surgical results?

Patients will be randomly assigned to the study but will know which technique will be used in their particular case. Patients included in this study will undergo subcutaneous mastectomy or skin-sparing mastectomy using standard techniques with simultaneous implantation using PTFE mesh or allogeneic dura mater graft. In our opinion, the mesh and graft will stabilize the projections of the inframammary fold and breast implant.

After the surgery, all minor and major complications will be recorded for 6 months. For this, both physical examination and radiological diagnostic methods will be used, including breast ultrasound and MRI with contrast. Revision surgeries will be performed if necessary.

Projections of the inframammary fold and breast implant will also be measured in order to determine the effectiveness of the compared techniques.

Patients will be asked to complete the BREAST-Q Version 2.0© Reconstruction Module questionnaire to determine satisfaction with the surgical outcome.

The results of the study will help the professional community to determine the most effective method of Implant-based Breast reconstruction and will be published in peer-reviewed scientific journals.

Conditions

• Breast Cancer Stage I
• Breast Cancer Stage II
• In Situ Breast Cancer

Interventions

PROCEDURE

Implant-based breast reconstruction using polytetrafluoroethylene mesh

Patients will undergo subcutaneous or skin-sparing mastectomy using the standard technique. Simultaneously, breast reconstruction will be performed using a breast implant. The lower pole of the implant and the inframammary fold will be additionally reinforced with polytetrafluoroethylene (PTFE) mesh. The lower edge of the mesh is sutured in the projection of the inframammary fold, and the upper edge is sutured to the pectoralis major muscle.

PROCEDURE

Implant-based breast reconstruction using Allogeneic dura mater graft

Patients will undergo subcutaneous or skin-sparing mastectomy using the standard technique. Simultaneously, breast reconstruction will be performed using a breast implant. The lower pole of the implant and the inframammary fold will be additionally reinforced with an allogeneic dura mater graft. The lower edge of the mesh is sutured in the projection of the inframammary fold, and the upper edge is sutured to the pectoralis major muscle.

Sponsors & Collaborators

• Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

  collaborator OTHER_GOV

• Branch Office of "Hadassah Medical Ltd"

  lead OTHER

Principal Investigators

• Alla Kartasheva, PhD · The Branch of Hadassah Medical LTD

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-01

Primary Completion

2025-08-31

Completion

2026-02-28

Countries

• Russia

Study Locations