Experimental and Clinical Investigation of the Implant Surface Roughness Reduction Effect on Early-stage Fibrosis

Summary

The goal of this single-center, randomised double-blinded trial is to compare the early stage fibrosis progression around conventional textured expander and the SmoothSilk® expander with reduced surface roughness in women undergoing bilateral nipple or skin sparing mastectomy in a prophylactic setting followed by tissue-expander based breast reconstruction. Researchers will compare intra-individually, the conventional textured expander CPX®(Mentor) and the SmoothSilk® (Motiva) expander (i) to gain a comprehensive insight into immunological mechanisms occurring at the timepoint of expander insertion (within the first days after implantation) based on WBF analysis in vitro, (ii)to determine the role and function of immune cells in a rather early stage of capsule formation (6-8 months after implantation) and under well-defined conditions in humans as well as (iii)to analyze the aesthetic outcome and clinical parameters after bilateral implant-based reconstruction using two expanders with varying surface topography within the individual patient (intra-individually).

Conditions

• Capsular Contracture Associated With Implant
• Foreign-Body Reaction
• Wounds and Injuries
• Tissue Expander Disorder

Interventions

OTHER

Patient Satisfaction Questionnaire

During regular clinical examinations patient will go through a short questionnaire at week 4, 16 and 24 to check patient satisfaction with expanders

DIAGNOSTIC_TEST

Pregnancy test

Pre-op; to sufficiently check pregnancy as exclusion criteria

PROCEDURE

Blood draw

pre- expander implantation, alongside anaesthesia pre- expander explantation and exchange with definite implant alongside anaesthesia - no additional vein irritation needed

PROCEDURE

Expander based breast reconstruction

implantation of 2 different expanders intraindividually

PROCEDURE

Ultrasound of breast

Measurement of capsular thickness pre- expander removal

OTHER

S(AE )monitoring

(S)AE evaluation will be performed from Visit 1 (Day 0 = Expander implantation) to Visit 15 (Day 168-196 = Reoperation) according to visit plan.

Sponsors & Collaborators

• Medical University Innsbruck

  lead OTHER

Principal Investigators

• Dolores Wolfram-Raunicher, Dr. · Medical University of Innsbruck, Department for Plastic Surgery

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-01-20

Primary Completion

2024-01-01

Completion

2024-02-13

Countries

• Austria

Study Locations