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

Phase 4

Completed

• Conditions: Breast Cancer; Hereditary Breast and Ovarian Cancer Syndrome
• Interventions: Device: TiLoop Bra; Device: Protexa

• Registration Number: NCT02562170
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Primary Completion: 2015-04
• Study Completion: 2015-05
• Status Verified: 2015-09
• Study First Submitted: 2015-09-18
• Study First Submitted QC: 2015-09-26
• Last Update Submitted: 2015-09-26
• Study First Posted: 2015-09-29
• Last Update Posted: 2015-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

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Exclusion Criteria

• prior local radiotherapy
• inflammatory breast cancer

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TiLoop Bra	TiLoop Bra	immediate breast reconstruction with an implant and TiLoop Bra
Protexa	Protexa	immediate breast reconstruction with an implant and Protexa

Primary Outcome Measures

Name	Time	Method
complications	6 months after surgery	hematoma, seroma, infection, skin necrosis, capsular contracture, implant loss
change of baseline cosmetic outcome after 3 and 6 months	up to two weeks after surgery (=baseline), 3 and 6 months after surgery	four point Harris Scale (1=poor, 4=excellent)
change of baseline patient quality of life after 3 and 6 months	up to two weeks after surgery (=baseline), 3 and 6 months after surgery	questionnaire
change of baseline thickness of the tissue overlying the implant at the lower pole after 3 and 6 months	up to two weeks after surgery (=baseline), 3 and 6 months after surgery	The thickness of the tissue covering the implant in the lower pole im mm measured by ultrasound

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria