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

NCT ID: NCT06931548

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2026-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Implant-based breast reconstruction using polytetrafluoroethylene mesh

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Implant-based breast reconstruction using Allogeneic dura mater graft

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER_GOV

Sponsor Role: collaborator

Branch Office of "Hadassah Medical Ltd"

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alla Kartasheva, PhD

Role: PRINCIPAL_INVESTIGATOR

The Branch of Hadassah Medical LTD

Locations

The Branch of Hadassah Medical LTD

Moscow, Skolkovo Innovation Center, Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Artem Mishin, MD

Role: CONTACT

dr.mishin@mail.ru

+7 (910) 175-98-75

Facility Contacts

Igor Utyashev, PhD

Role: primary

i.utyashev@hadassah.moscow

+7 (495) 800-10-00 ext. 7041

Other Identifiers

BREAST-ONE

Identifier Type: -

Identifier Source: org_study_id