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

Official title

Ways of Retaining the Inframammary Fold in Implant-based Breast Surgery Using Polytetrafluoroethylene (PTFE) Mesh or Allogeneic Dura Mater Graft

Overview

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.

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.

Primary outcome measures

• Incidence of major and minor complications [Time frame: within 6 months from the date of surgery]

Secondary outcome measures (2)

• Evaluation of changes in projections of the implant and inframammary fold [Time frame: within 6 months from the date of surgery]
• Quality of life [Time frame: within 6 months from the date of surgery]

Eligibility criteria

Inclusion criteria

• White women;
• Breast cancer stage 0-II;
• Indications for breast reconstruction;
• Consent to participate in the study and photographic documentation.

Exclusion criteria

• Non-white women;
• Breast cancer stage III-IV;
• Tubular breast;
• Mental and cognitive health disorders;
• Failure to comply with recommendations in the postoperative period (premature physical activity, not wearing compression underwear, missing scheduled visits, refusal of photo documentation);
• Patient refusal to participate in the study at any stage.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Russia · 1 center

• The Branch of Hadassah Medical LTD — Moscow

Identifiers

NCT: NCT06931548 · BREAST-ONE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗