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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02562170
• Other study ID #: 1401/2013
• Status: Completed
• Phase: Phase 4
• First received: September 18, 2015
• Last updated: September 26, 2015
• Start date: July 2013
• Est. completion date: May 2015

Study information

• Verified date: September 2015
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Medicines and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breast Cancer
• Hereditary Breast and Ovarian Cancer Syndrome

Intervention

Device:
• TiLoop Bra

• Protexa

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complications	hematoma, seroma, infection, skin necrosis, capsular contracture, implant loss	up to two weeks after surgery	Yes
Primary	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	No
Primary	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	No
Primary	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	No
Primary	complications	hematoma, seroma, infection, skin necrosis, capsular contracture, implant loss	3 months after surgery	Yes
Primary	complications	hematoma, seroma, infection, skin necrosis, capsular contracture, implant loss	6 months after surgery	Yes