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This study aims to evaluate the efficacy of using a polyester mesh endoprosthesis with a fluoropolymer coating in reducing postoperative complications, particularly protrusions, following subcutaneous mastectomy with simultaneous prepectoral placement of textured breast implants in women with breast cancer
The study includes female patients aged 18 and above with a verified breast cancer diagnosis, ECOG performance status 0-1, and clinical stage T1-T3, N0-3, M0, who provide informed consent. Exclusion criteria involve intolerance or allergic reactions to mesh endoprostheses or implants and a subcutaneous adipose tissue thickness of less than 5 mm (measured via Pinch Test). Participants will be non-randomly allocated into two groups: the main group, receiving a polyester mesh endoprosthesis with fluoropolymer coating alongside textured implants, and the control group, receiving textured implants alone. Surgical procedures will involve subcutaneous mastectomy with implant placement based on preoperative measurements of breast dimensions, with or without nipple-areolar complex preservation. Postoperative follow-ups at 1, 3-6, and 9-12 months will assess complications such as protrusions, seromas, implant contouring (rippling), capsular contracture, and dystopia via physical examination and ultrasound. The hypothesis posits that the use of mesh endoprostheses will lower protrusion rates compared to standard implant placement, offering a potential advancement in reducing postoperative risks in breast reconstruction for breast cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main group | Experimental | The main group will consist of patients with the planned volume of surgical intervention: subcutaneous mastectomy using a polyester mesh endoprosthesis with a fluoropolymer coating and simultaneous prepectoral placement of textured implants. |
|
| Control group | Other | The control group will consist of patients who undergo surgical treatment for subcutaneous mastectomy, with simultaneous placement of textured breast implants with no polyester mesh endoprosthesis with a fluoropolymer coating |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subcutaneous mastectomy using a fluoropolymer-coated polyester mesh endoprosthesis with simultaneous prepectoral placement of textured implants. | Procedure | For this group of patients, the planned volume of surgical intervention is: subcutaneous mastectomy using a polyester mesh endoprosthesis with a fluoropolymer coating and one-stage prepectoral installation of textured implants. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of protrusions throughout the year | Implant protrusion is a complication that occurs after reconstructive plastic surgery. In this type of surgery, the implant is displaced from its anatomically correct position leading to its protrusion through the skin. This happens when the integrity or strength of the tissues that hold the implant (such as capsules, muscles, and fascia) is compromised. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 1. Frequency of seroma 2. Frequency of Rippling 3. Frequency of Capsular contracture 4. Frequency of Dystopia |
|
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Petersburg State University | Saint Petersburg | Russia |
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Main group- The main group will consist of patients undergoing surgical treatment for subcutaneous mastectomy using a polyester mesh endoprosthesis with a fluoropolymer coating, with simultaneous prepectoral placement of textured implants.
Control group-The control group will consist of patients who undergo surgical treatment for subcutaneous mastectomy, with simultaneous placement of textured breast implants.
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| Subcutaneous mastectomy with simultaneous prepectoral placement of textured implants. | Procedure | This group of patients will undergo surgical intervention in deep subcutaneous mastectomy with simultaneous prepectoral placement of textured implants. |
|
| 1 year |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D015414 | Mastectomy, Subcutaneous |
| ID | Term |
|---|---|
| D008408 | Mastectomy |
| D013514 | Surgical Procedures, Operative |
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