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| Name | Class |
|---|---|
| Comenius University | OTHER |
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Allogenic acellular dermal matrix has been used in burn injuries or abdominal walls reconstructions. However, it is solely used in breast reconstructions after breast carcinoma amputation. The efficacy of such allogenic dermal matrix can be advantageous when compared to current treatment options, however, this has to be proved.
This is a prospective study, where patients undergoing breast reconstruction surgery using acellular dermal matrix (ADM) with expander use in first phase of reconstruction will be included. The permanent breast implants will be implanted approximately half year during second surgery. Acellular dermal matrix is a soft tissue graft that is formed by decellularization, however with intact extracellular dermal matrix. Such structure is able to re-create adequate skeleton for host cells with subsequent incorporation and revascularization. The safety and appropriateness of such ADM in breast reconstruction surgery will be analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acellular dermal matrix arm | The females undergoing breast reconstruction surgery after breast removal because of breast cancer. The breast reconstruction will be performed using acellular dermal matrix implantation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acellular dermal matrix implantation | Other | Acellular dermal matrix obtained from Central tissue bank, University Hospital Bratislava, will be used for acellular dermal matrix implantation. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of complications in patients receiving acellular dermal matrix evaluated at 6 months after primary implantation | All patients between January 2010 and June 2014 undergoing primary ADM implantation will be evaluated at 6 months after implantation for early ex-plantations, inflammation, deformities of the implants, allergic reactions will be observed in patients undergoing primary ADM implantation at 6 months until second permanent implantation is performed. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Histologic evaluation of ADM implants upon planned explantations | All patients between January 2012 and June 2014 after primary ADM transplantation will be evaluated. Analysis of cell composition, leukocytes at place, vessel formation and dysplasias will be performed | 6 months |
| Satisfaction with breast reconstruction outcome evaluated by Breast-Q questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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The cohort will be selected from patients with breast cancer and in remission, sent to plastic and reconstruction surgery clinics for breast reconstruction after therapeutical mastectomy.
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| Name | Affiliation | Role |
|---|---|---|
| Miroslav Bdzoch, MD, PhD | University Hospital Bratislava, Pazitkova 4, Bratislava, Slovakia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Bratislava | Bratislava | 82101 | Slovakia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28812172 | Derived | Bohac M, Varga I, Polak S, Dragunova J, Fedeles J Sr, Koller J. Delayed post mastectomy breast reconstructions with allogeneic acellular dermal matrix prepared by a new decellularizationmethod. Cell Tissue Bank. 2018 Mar;19(1):61-68. doi: 10.1007/s10561-017-9655-0. Epub 2017 Aug 16. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin 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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Acellular dermal tissue after primary reconstruction will be harvested prior to second surgery with permanent implant.
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Physical and psychical as well as sexual well-being with outcome will be evaluated by specifically for this purpose developed questionnaire (The Breast-Q questionnaire) after permanent breast implant implantation at 2 years |
| 2 years |
| D017437 |
| Skin and Connective Tissue Diseases |