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Randomized controlled trial to look at early complications, cosmetic outcome, patient satisfaction and thickness of the tissue overlying the implant at the lower pole in immediate implant based breast reconstruction after Skin or Nipple Sparing Mastectomy with either a mesh (TiLOOP Bra) or an ADM (Protexa). Multicenter austrian trial with four breast cancer centers, 50 patients randomized 1:1 in the TiLoop or Protexa group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TiLoop Bra | Active Comparator | immediate breast reconstruction with an implant and TiLoop Bra |
|
| Protexa | Active Comparator | immediate breast reconstruction with an implant and Protexa |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TiLoop Bra | Device |
| ||
| Protexa |
| Measure | Description | Time Frame |
|---|---|---|
| complications | hematoma, seroma, infection, skin necrosis, capsular contracture, implant loss | up to two weeks after surgery |
| change of baseline patient quality of life after 3 and 6 months | questionnaire | up to two weeks after surgery (=baseline), 3 and 6 months after surgery |
| change of baseline cosmetic outcome after 3 and 6 months | four point Harris Scale (1=poor, 4=excellent) | up to two weeks after surgery (=baseline), 3 and 6 months after surgery |
| change of baseline thickness of the tissue overlying the implant at the lower pole after 3 and 6 months | The thickness of the tissue covering the implant in the lower pole im mm measured by ultrasound | up to two weeks after surgery (=baseline), 3 and 6 months after surgery |
| complications | hematoma, seroma, infection, skin necrosis, capsular contracture, implant loss | 3 months after surgery |
| complications | hematoma, seroma, infection, skin necrosis, capsular contracture, implant loss | 6 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daphne Gschwantler-Kaulich, Ass.Prof.Dr. | Medical University Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26947961 | Derived | Gschwantler-Kaulich D, Schrenk P, Bjelic-Radisic V, Unterrieder K, Leser C, Fink-Retter A, Salama M, Singer C. Mesh versus acellular dermal matrix in immediate implant-based breast reconstruction - A prospective randomized trial. Eur J Surg Oncol. 2016 May;42(5):665-71. doi: 10.1016/j.ejso.2016.02.007. Epub 2016 Feb 23. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D061325 | Hereditary Breast and Ovarian Cancer Syndrome |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| D017437 |
| Skin and Connective Tissue Diseases |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |