NCT05648929

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

Completed NA Last updated 18 March 2024

What this trial tests

NA trial testing Patient Satisfaction Questionnaire in Capsular Contracture Associated With Implant in 14 participants. Completed in 13 February 2024.

Timeline

20 January 2021

Primary endpoint
1 January 2024

13 February 2024

Quick facts

Lead sponsor	Medical University Innsbruck
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	other
Enrollment	14
Start date	20 January 2021
Primary completion	1 January 2024
Estimated completion	13 February 2024
Sites	1 location across Austria

Drugs / interventions tested

• Patient Satisfaction Questionnaire
• Pregnancy test — full drug profile →
• Blood draw — full drug profile →
• Expander based breast reconstruction
• Ultrasound of breast
• S(AE )monitoring

Conditions studied

• Capsular Contracture Associated With Implant — all drugs for Capsular Contracture Associated With Implant →
• Foreign-Body Reaction — all drugs for Foreign-Body Reaction →
• Wounds and Injuries — all drugs for Wounds and Injuries →
• Tissue Expander Disorder — all drugs for Tissue Expander Disorder →

Sponsor

Medical University Innsbruck

Who can join

Adults 18 to 99, female only, with Capsular Contracture Associated With Implant or Foreign-Body Reaction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Quantitative Proteomic Characterization of Foreign Body Response towards Silicone Breast Implants Identifies Chronological Disease-Relevant Biomarker Dynamics.
   Schoberleitner I, Faserl K, Sarg B, Egle D, et al · · 2023 · cited 14× · PMID 36830674 · DOI 10.3390/biom13020305
2. Is It All about Surface Topography? An Intra-Individual Clinical Outcome Analysis of Two Different Implant Surfaces in Breast Reconstruction.
   Schoberleitner I, Augustin A, Egle D, Brunner C, et al · · 2023 · cited 13× · PMID 36835850 · DOI 10.3390/jcm12041315
3. Silicone implant surface microtopography modulates inflammation and tissue repair in capsular fibrosis.
   Schoberleitner I, Faserl K, Tripp CH, Pechriggl EJ, et al · · 2024 · cited 9× · PMID 38566997 · DOI 10.3389/fimmu.2024.1342895
4. Surface Topography, Microbial Adhesion, and Immune Responses in Silicone Mammary Implant-Associated Capsular Fibrosis.
   Schoberleitner I, Baier L, Lackner M, Zenz LM, et al · · 2024 · cited 6× · PMID 38542137 · DOI 10.3390/ijms25063163
5. Don't judge an implant by its cover: how the foreign body response and fibrotic capsule might be harnessed for good.
   Dickenson ME, Oakes RS, Morris AH. · · 2026 · cited 3× · PMID 41551433 · DOI 10.1038/s44385-025-00053-7