Clinical trial · Interventional
Protexa® Versus TiLoopBra® in Immediate Breast Reconstruction- A Pilot Study
NCT02562170CI-TRIAL-00019245completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Hereditary Breast and Ovarian Cancer Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Protexa | Device | — | UNRESOLVED |
| TiLoop Bra | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- TiLoop Bra
- description
- immediate breast reconstruction with an implant and TiLoop Bra
- interventionNames
- Device: TiLoop Bra
- type
- ACTIVE_COMPARATOR
- label
- Protexa
- description
- immediate breast reconstruction with an implant and Protexa
- interventionNames
- Device: Protexa
Primary outcomes (6)
- measure
- complications
- timeFrame
- up to two weeks after surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGschwantler-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. PMID 26947961