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

NCT05648929 | Completed DMC

• 1 other identifier: EIT2020
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

prophylactic NSME (nipple sparing mastectomy); implant-based breast reconstruction; medical grade silicone; SMI (silicone mammary implants); Foreign body response to SMI; SMI encapsulation; immunoreactivity of SMI surface topography; capsular fibrosis; immunomodulation by SMI-surface roughness

Outcome Measures

Primary Outcomes (4)

• wound bed fluid Immune cell profile (composition)

  immediately after implantation wound drain fluid will be immune profiled for cell populations by flow cytometry to gain a comprehensive insight into immunological mechanisms occurring at the time-point of expander insertion (within the first days after implantation) and evaluate potential effects of expander surface roughness

  1 to 5 days post expander implantation

• wound bed fluid wound proteome composition

  immediately after implantation wound drain fluid will be proteomically profiled by Mass Spectrometry for tissue repair and foreign body response to gain a comprehensive insight into immunological triggers and mechanisms occurring at the time-point of expander insertion (within the first days after implantation) and evaluate potential effects of expander surface roughness

  1 to 5 days post expander implantation

• wound bed fluid Immune cell activity

  immediately after implantation wound drain fluid will be immune profiled for cell activity by qPCR analysis of cytokine expression to gain a comprehensive insight into immunological mechanisms occurring at the time-point of expander insertion (within the first days after implantation) and evaluate potential effects of expander surface roughness

  1 to 5 days post expander implantation

• wound bed fluid wound microbiome composition

  will be NextGen sequenced for microbiome colonisation, population, and biofilm formation to gain a comprehensive insight into immunological triggers and mechanisms occurring at the time-point of expander insertion (within the first days after implantation) and evaluate potential effects of expander surface roughness

  1 to 5 days post expander implantation

Secondary Outcomes (5)

• Intracapsular immune cell composition

  At reoperation; 6-8 months post expander implantation

• Clinical evaluation of aesthetic outcome and postoperative complications

  2, 4 and 16 weeks and at reoperation; 6-8 months post expander implantation

• Intracapsular immune cell activity

  At reoperation; 6-8 months post expander implantation

• Ultrasound evaluation of capsular thickness and postoperative complications

  At reoperation; 6-8 months post expander implantation

• Expander Satisfaction and comfortability evaluation by Questionnaire

  At reoperation; 6-8 months post expander implantation

Study Arms (2)

the conventional expander Mentor CPX4 (MENTOR)

ACTIVE COMPARATOR

intraindividual comparison of two differentially rough tissue expanders Arm description: women undergoing prophylactic bilateral NSME and simultaneous tissue-expander based reconstruction with conventionally textured expander with surface roughness 60µM Ra

Other: Patient Satisfaction Questionnaire; Diagnostic Test: Pregnancy test; Procedure: Blood draw; Procedure: Expander based breast reconstruction; Procedure: Ultrasound of breast; Other: S(AE )monitoring

the expander SmoothSilk(Motiva) with reduced surface roughness

ACTIVE COMPARATOR

intraindividual comparison of two differentially rough tissue expanders Arm description: women undergoing prophylactic bilateral NSME and simultaneous tissue-expander based reconstruction with reduced textured expander with surface roughness 4µM Ra

Other: Patient Satisfaction Questionnaire; Diagnostic Test: Pregnancy test; Procedure: Blood draw; Procedure: Expander based breast reconstruction; Procedure: Ultrasound of breast; Other: S(AE )monitoring

Interventions

Patient Satisfaction Questionnaire OTHER

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

the conventional expander Mentor CPX4 (MENTOR); the expander SmoothSilk(Motiva) with reduced surface roughness

Pregnancy test DIAGNOSTIC_TEST

Pre-op; to sufficiently check pregnancy as exclusion criteria

the conventional expander Mentor CPX4 (MENTOR); the expander SmoothSilk(Motiva) with reduced surface roughness

Blood draw PROCEDURE

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

the conventional expander Mentor CPX4 (MENTOR); the expander SmoothSilk(Motiva) with reduced surface roughness

Expander based breast reconstruction PROCEDURE

implantation of 2 different expanders intraindividually

the conventional expander Mentor CPX4 (MENTOR); the expander SmoothSilk(Motiva) with reduced surface roughness

Ultrasound of breast PROCEDURE

Measurement of capsular thickness pre- expander removal

the conventional expander Mentor CPX4 (MENTOR); the expander SmoothSilk(Motiva) with reduced surface roughness

S(AE )monitoring OTHER

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

the conventional expander Mentor CPX4 (MENTOR); the expander SmoothSilk(Motiva) with reduced surface roughness

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Female sex
• High risk family history for mammary and/or ovarian cancer
• Planned prophylactic mastectomy with simultaneous breast reconstruction
• Signed informed consent form

You may not qualify if:

• Confirmed sever Coagulation disorder, representing a potential contraindication for the elective surgery
• Confirmed Rheumatic disease accompanied by obligatory intake of immunomodulating therapeutic agents
• Confirmed severe renal functional disorder: Renal insufficiency status IV or V
• Active hematological or oncological disease
• HIV-Infection
• Hepatitis-Infection
• Pregnancy or breast feeding
• Intake of anti-inflammatory drugs
• Carrier of silicone implants (e.g. gastric banding, mammary implants)
• Subject is currently participating or intends to participate in another clinical trial that may interfere with the protocol of this study
• Patients who have implanted devices that could be affected by a magnetic field (e.g., pacemakers, drug infusion devices, artificial sensing devices) \* patients with removable devices such as removable diabetes pumps, sensors and transmitter might still part take,
• Patients with alteration in hematologic and serum protein reference values post-chemotherapy.
• When there is a residual malignancy in the intended expansion site.
• Existing tissue at the intended expansion site is not adequate according to the surgeon's criteria, because of previous radiation therapy, ulcerations, vascular compromise, history of compromised wound healing, or scar deformity.
• Radiation therapy before or after the expander placement can be associated with a higher rate of complications during the expansion and final implantation phases of the reconstructive process.

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Medical University of Innsbruck, Department for Plastic, Aethetic and Reconstructive Surgery

Innsbruck, Tyrol, 6020, Austria

Location

Related Publications (2)

• Schoberleitner I, Augustin A, Egle D, Brunner C, Amort B, Zelger B, Brunner A, Wolfram D. Is It All about Surface Topography? An Intra-Individual Clinical Outcome Analysis of Two Different Implant Surfaces in Breast Reconstruction. J Clin Med. 2023 Feb 7;12(4):1315. doi: 10.3390/jcm12041315.

  PMID: 36835850 RESULT

• Schoberleitner I, Faserl K, Sarg B, Egle D, Brunner C, Wolfram D. Quantitative Proteomic Characterization of Foreign Body Response towards Silicone Breast Implants Identifies Chronological Disease-Relevant Biomarker Dynamics. Biomolecules. 2023 Feb 6;13(2):305. doi: 10.3390/biom13020305.

  PMID: 36830674 RESULT

Related Links

• Results reference

MeSH Terms

Conditions

Foreign-Body Reaction; Wounds and Injuries

Interventions

Pregnancy Tests; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Foreign Bodies

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Obstetrical and Gynecological; Investigative Techniques; Specimen Handling; Punctures; Surgical Procedures, Operative

Study Officials

• Dolores Wolfram-Raunicher, Dr.

  Medical University of Innsbruck, Department for Plastic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: randomised double-blinded trial: A total of 14 patients will receive either Motiva SmoothSilk® or other routinely used expander (Mentor CPX™4) randomized to left or right breast after mastectomy. Patient and laboratory expert will be double-blinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: intraindividual comparative analysis of two different devices implanted within one individual patient.

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: December 13, 2022
• Study Start: January 20, 2021
• Primary Completion: January 1, 2024
• Study Completion: February 13, 2024
• Last Updated: March 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)