Clinical trial NCT06931548: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Stage I
Breast Cancer Stage II
In Situ Breast Cancer
Keywords: implant-based breast reconstruction
breast cancer
PTFE mesh
Lead sponsor: Branch Office of "Hadassah Medical Ltd"
Sponsor class: OTHER
Collaborators: name: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
First posted: 2025-04-17
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Incidence of major and minor complications
timeFrame: within 6 months from the date of surgery
Secondary outcomes:
measure: Evaluation of changes in projections of the implant and inframammary fold
timeFrame: within 6 months from the date of surgery
measure: Quality of life
timeFrame: within 6 months from the date of surgery
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: The Branch of Hadassah Medical LTD
state: Skolkovo Innovation Center
Study officials:
affiliation: The Branch of Hadassah Medical LTD
name: Alla Kartasheva, PhD
role: PRINCIPAL_INVESTIGATOR
References: