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

Medical University of Vienna

Status and phase: Completed; Phase 4

Conditions: Breast Cancer; Hereditary Breast and Ovarian Cancer Syndrome

Treatments: Device: Protexa; Device: TiLoop Bra

Study type: Interventional

Funder types: Other

Identifiers

NCT02562170

1401/2013

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

TiLoop Bra

Active Comparator group

Description:

immediate breast reconstruction with an implant and TiLoop Bra

Treatment:

Device: TiLoop Bra

Protexa

Active Comparator group

Description:

immediate breast reconstruction with an implant and Protexa

Treatment:

Device: Protexa