An interventional study of Implant-based breast reconstruction using polytetrafluoroethylene mesh and Implant-based breast reconstruction using Allogeneic dura mater graft in Breast Cancer Stage I, Breast Cancer Stage II and In Situ Breast Cancer, sponsored by Branch Office of "Hadassah Medical Ltd". Recruiting at 1 site in Russian Federation. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-17.
Sponsored by Branch Office of "Hadassah Medical Ltd" · Not applicable, Interventional, and Treatment
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:
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 100 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Branch Office of "Hadassah Medical Ltd" is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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 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 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.
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.
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.
Time frame: within 6 months from the date of surgery
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.
Time frame: 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).
Time frame: within 6 months from the date of surgery
Plan to share: Yes — 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).
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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.
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Started Mar 2022 (actual). Primary completion is estimated for Aug 2025, 41 months after the start.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 41 months is above that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
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Branch Office of "Hadassah Medical Ltd"