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

NCT06931548 | Recruiting

• 1 other identifier: BREAST-ONE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

implant-based breast reconstruction; breast cancer; PTFE mesh

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Evaluation of changes in projections of the implant and inframammary fold

  within 6 months from the date of surgery

• Quality of life

  within 6 months from the date of surgery

Study Arms (2)

Polytetrafluoroethylene mesh

EXPERIMENTAL

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

Allogeneic dura mater graft

ACTIVE COMPARATOR

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

Interventions

Implant-based breast reconstruction using polytetrafluoroethylene mesh PROCEDURE

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.

Polytetrafluoroethylene mesh

Implant-based breast reconstruction using Allogeneic dura mater graft PROCEDURE

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.

Allogeneic dura mater graft

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Branch Office of "Hadassah Medical Ltd": lead
• Federal Research Clinical Center of Federal Medical & Biological Agency, Russia: collaborator

Study Sites (1)

The Branch of Hadassah Medical LTD

Moscow, Skolkovo Innovation Center, 121205, Russia

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Breast Carcinoma In Situ

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Alla Kartasheva, PhD

  The Branch of Hadassah Medical LTD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Artem Mishin, MD

CONTACT

+7 (910) 175-98-75; dr.mishin@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2025
• First Posted: April 17, 2025
• Study Start: March 1, 2022
• Primary Completion: August 1, 2025
• Study Completion: February 1, 2026
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 3 months and ending 3 years after the publication of results
• 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.

Locations

RU (1)