Protexa® Versus TiLoopBra® in Immediate Breast Reconstruction- A Pilot Study

Study Overview
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Brief Summary
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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.

Official Title
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Protexa® Versus TiLoopBra® in Immediate Breast Reconstruction- A Pilot Study

Conditions
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Breast Cancer, Hereditary Breast and Ovarian Cancer Syndrome

Intervention / Treatment
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* Device: TiLoop Bra
* Device: Protexa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: breast cancer patients with indication for skin or nipple sparing mastectomy BRCA1/2 mutation carriers with indication for skin or nipple sparing mastectomy Exclusion Criteria: prior local radiotherapy inflammatory breast cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TiLoop Bra<br>immediate breast reconstruction with an implant and TiLoop Bra | Device: TiLoop Bra<br> <br> |
| Active Comparator: Protexa<br>immediate breast reconstruction with an implant and Protexa | Device: Protexa<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast, reconstruction, mesh, acellular dermal matrix