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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer Stage I; Breast Cancer Stage II; In Situ Breast Cancer
• Intervention / Treatment: Procedure: Implant-based breast reconstruction using polytetrafluoroethylene mesh; Procedure: Implant-based breast reconstruction using Allogeneic dura mater graft

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Artem Mishin, MD; Phone Number: +7 (910) 175-98-75; Email: dr.mishin@mail.ru

Study Locations

• Russian Federation
  • Skolkovo Innovation Center
    • Moscow, Skolkovo Innovation Center, Russian Federation, 121205
      • Recruiting
      • The Branch of Hadassah Medical LTD
      • Contact: Igor Utyashev, PhD; Phone Number: 7041 +7 (495) 800-10-00; Email: i.utyashev@hadassah.moscow

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Polytetrafluoroethylene mesh; Patients in this group will undergo one-stage breast reconstruction using an implant and polytetrafluoroethylene (PTFE) mesh after subcutaneous or skin-sparing mastectomy.	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.
Active Comparator: Allogeneic dura mater graft; Patients in this group will undergo one-stage breast reconstruction using an implant and allogeneic dura mater graft after subcutaneous or skin-sparing mastectomy.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of major and minor complications	Major complications will be defined as complications that lead to revision surgery. These may include long-term seromas and hematomas, necrosis, infections that are not controlled by therapy or physical therapy. Also, displacement of the implant position by more than 2 cm. Minor complications will be defined as complications that do not require reoperation.	within 6 months from the date of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of changes in projections of the implant and inframammary fold	After the operation and after 6 months, the following distances will be measured: from the jugular notch to the nipple;; from the middle of the clavicle to the nipple;; from the anterior midline to the nipple;; from the inframammary fold to the nipple. Calipers are used for measurements, distances are measured in the metric system. These measurements will allow you to assess the change in the position of the implant and, as a result, the shape of the breast. Changes in distances immediately after surgery and the same distances after 6 months by more than 1 cm (0.39 inches) will be considered a significant displacement of the implant.	within 6 months from the date of surgery
Quality of life	After surgery and 6 months later, patients will be asked to complete the BREAST-Q Version 2.0© Reconstruction Module questionnaire: "Physical well-being: chest";; "Sexual well-being";; "Psychosocial well-being";; "Satisfaction with breast". The BREAST-Q© is a rigorously developed patient-reported outcome (PRO) measure designed to evaluate outcomes among women undergoing different types of breast surgery. In this study, the "Reconstructive Module" of the questionnaire will be used. There is no overall or total BREAST-Q© score, only scores for each independent scale. All BREAST-Q© scales are transformed into scores that range from 0-100. The scores are computed by adding the response items together and then converting the raw sum scale score to a score from 0-100. For all BREAST-Q© scales, a higher score means greater satisfaction or better QOL (depending on the scale).	within 6 months from the date of surgery

Collaborators and Investigators

• Sponsor: Branch Office of "Hadassah Medical Ltd"
• Collaborators: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
• Investigators: Principal Investigator: Alla Kartasheva, PhD, The Branch of Hadassah Medical LTD

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: April 6, 2025
• First Submitted That Met QC Criteria: April 15, 2025
• First Posted (Actual): April 17, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: breast cancer; implant-based breast reconstruction; PTFE mesh
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Skin Diseases; Breast Diseases; Carcinoma; Carcinoma in Situ; Breast Carcinoma In Situ; Breast Neoplasms
• Other Study ID Numbers: BREAST-ONE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie the results in a publication will be formed into a single tabular data array and placed in cloud storage. Access to viewing this array will be provided upon request of researchers or scientific publications (through the corresponding author).
• IPD Sharing Time Frame: Beginning 3 months and ending 3 years after the publication of results
• IPD Sharing Access Criteria: The data obtained as a result of the study will be published in scientific journals in general form. Accordingly, we see no reason not to provide access to the original data - the data array. In case of interest in the array and any additional information, it will be necessary to contact the members of the research group - the co-authors of the publication. According to generally accepted rules, when publishing an article, the e-mail address of at least one of the co-authors is indicated. Thus, if necessary, interested parties can write to the co-authors directly to provide access.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No