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The goal of this retrospective observational trial is to compare two different devices, used in implant-based breast reconstruction, called acellular dermal matrices, which are a sort of collagen patch that integrates with the tissues of the patient and helps in contrasting the collateral effects of radiotherapy (capsular contracture, implant loss)
The main questions the study aims to answer are:
Researchers will compare patients who receive the porcine-derived adm and the patients who receive bovine-derived adm to see if there is a difference in terms of capsular contracture reduction, aestethic result and complications.
Radiotherapy is highly effective in breast cancer treatment, yet it impairs satisfactory implant-based reconstruction, due to high rates of capsular contracture and implant loss. This said, a fervent investigtion exists upon solutions that can make implant-based reconstruction safer and aesthetically satisfying, including the use of acellular dermal matrices. We retrospectively want to analyze our ADM-assisted post-RT implant-based breast reconstructions comparing two different matrices (porcine and bovine), when autologous reconstruction was contraindicated, to assess eventual differences in efficacy and risk profile of the devices. We want to further stratify the population in 4 groups based on clinical presentation to assess if there was a group where ADMs proves to perform better (Group A - previous quadrantectomy, Group B - previous mastectomy and expander reconstruction, Group C - previous mastectomy and implant reconstruction, Group D - prior quadrantectomy followed by mastectomy and implant reconstruction).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POST QUART NATIVE | Native adm used in the setting of mastectomy and implant reconstruction after QUART |
| |
| POST QUART VERITAS | Veritas adm used in the setting of mastectomy and implant reconstruction after QUART |
| |
| POST EXPANDER NATIVE | Native adm used in the setting of expander removal and implant positioning after mastectomy + RT |
| |
| POST EXPANDER VERITAS | Veritas adm used in the setting of expander removal and implant positioning after mastectomy + RT |
| |
| IMPLANT EXCHANGE NATIVE | Native adm used in the setting of implant exchange after mastectomy + RT |
| |
| IMPLANT EXCHANGE VERITAS |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acellular dermal matrix implant for breast reconstruction | Device | acellular dermal matrix implant in implant-based breast reconstruction in patients receiving radiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| ADM efficacy and risk profile comparison | Does one dermal matrix perform better than the other in terms of efficacy and complication rates? | 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Best clinical setting for ADM use | Is there a subgroup of patient where the use of ADM proves more beneficial than others? | 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| ADM comparison in each clinical setting group | Is there a type of dermal matrix that performs better than the other in a specific subgroup of patients? | 60 months |
Inclusion Criteria:
Exclusion Criteria:
female patients undergoing breast reconstruction after mastectomy
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The study focuses on female patients undergoing implant based reconstruction after radiotherapy assisted by the use of an acellular dermal matrix.
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Vittorio Emanuele Lisa, MD | Istituto Europeo di Oncologia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Institute of Oncology | Milan | Lombardy | 20141 | Italy |
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Veritas adm used in the setting of implant exchange after mastectomy + RT |
|
| IMPANT EXCHANGE AFTER QUART NATIVE | Native adm used in the setting of implant exchange after QUART+ Mastectomy and implant reconstruction |
|
| IMPLANT EXCHANGE AFTER QUART VERITAS | Veritas adm used in the setting of implant exchange after QUART+ Mastectomy and implant reconstruction |
|
| ID | Term |
|---|---|
| D057910 | Implant Capsular Contracture |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D005549 | Foreign-Body Reaction |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011475 | Prosthesis Failure |
| D011183 | Postoperative Complications |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D016462 | Mammaplasty |
| ID | Term |
|---|---|
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D019651 | Plastic Surgery Procedures |
| D013514 | Surgical Procedures, Operative |
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