Experimental and Clinical Investigation of the Implant Surface Roughness Reduction Effect on Early-stage Fibrosis
NCT ID: NCT05648929
Last Updated: 2024-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
2021-01-20
2024-02-13
Brief Summary
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Detailed Description
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Directly postoperatively at day 1-5 after expander implantation, wound bed fluid will be collected and proteinaceous and cellular components will be analyzed via FACS (flow cytometry), molecular (RNA, protein) assays and microbiome testing platform.
Phenotypical and functional analyses will be performed for capsular tissue and blood as well as PCR (polymerase chain reaction) assays for bacterial antigens when expanders are changed to definite implants. Expanders will also undergo sonication to check for bacterial contamination. Peri-capsular tissue samples will be evaluated using scanning electron microscopy-energy dispersive x-ray spectroscopy (SEM-EDS) to identify sites with/without titanium particles (Titan-Bra debris). And breast ultrasound will be performed to detect capsular thickness before the reoperation.
During regular clinical examinations patients will go through a short questionnaire at week 4 and 16 to check patient satisfaction with expanders and adverse events will be monitored. (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 main question\[s\] it aims to answer are:
1. Does the immune cell profile differ within the wound-bed fluid (WBF) directly after implantation? Do the investigators see different activation patterns or distribution patterns of immune cells within the WBF on the conventional expander reconstructed side versus the SmoothSilk® (Motiva) reconstructed side?
2. Does the immune cell profile differ within the capsular tissue formed around conventional expanders versus SmoothSilk® (Motiva) expanders?
3. Which cytokines are mainly expressed in the early capsular tissue (conventional expander versus SmoothSilk® (Motiva) and do the investigators see differences in comparison with those of peripheral blood?
4. Does the cellular composition (histology) show different distribution patterns of immune cells and ECM proteins in these capsules?
5. Do the investigators see differences concerning bacterial \& fungi contamination in WBF and on expander shells at the time point of explantation (sonication and PCR as well as next-generation DNA sequencing for bacteria and fungi)
6. Do the investigators see titanium wear particle incorporation into peri-capsular tissue? Is there a difference between the conventional expanders versus SmoothSilk® (Motiva) expanders after 6-8 months?
7. Do the investigators see any differences in outcome analysis between the conventional expanders versus Motiva nano-textured expanders after 6-8 months (Seroma formation, Implant dislocation, thickness of capsule)?
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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the conventional expander Mentor CPX4 (MENTOR)
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
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
Pregnancy test
Pre-op; to sufficiently check pregnancy as exclusion criteria
Blood draw
pre- expander implantation, alongside anaesthesia pre- expander explantation and exchange with definite implant alongside anaesthesia - no additional vein irritation needed
Expander based breast reconstruction
implantation of 2 different expanders intraindividually
Ultrasound of breast
Measurement of capsular thickness pre- expander removal
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.
the expander SmoothSilk(Motiva) with reduced surface roughness
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
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
Pregnancy test
Pre-op; to sufficiently check pregnancy as exclusion criteria
Blood draw
pre- expander implantation, alongside anaesthesia pre- expander explantation and exchange with definite implant alongside anaesthesia - no additional vein irritation needed
Expander based breast reconstruction
implantation of 2 different expanders intraindividually
Ultrasound of breast
Measurement of capsular thickness pre- expander removal
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.
Interventions
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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
Pregnancy test
Pre-op; to sufficiently check pregnancy as exclusion criteria
Blood draw
pre- expander implantation, alongside anaesthesia pre- expander explantation and exchange with definite implant alongside anaesthesia - no additional vein irritation needed
Expander based breast reconstruction
implantation of 2 different expanders intraindividually
Ultrasound of breast
Measurement of capsular thickness pre- expander removal
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.
Eligibility Criteria
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Inclusion Criteria
* Female sex
* High risk family history for mammary and/or ovarian cancer
* Planned prophylactic mastectomy with simultaneous breast reconstruction
* Signed informed consent form
Exclusion Criteria
* 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.
* Abscess or infection in the body in general.
* Participants with autoimmune diseases (e.g., lupus, scleroderma) or whose immune system is compromised (e.g., currently receiving immunosuppressive therapy such as steroids).
* Unsuitable tissue due to radiation damage on the chest wall, tight thoracic skin grafts or radical resection of the pectoralis major muscle.
18 Years
99 Years
FEMALE
Yes
Sponsors
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Medical University Innsbruck
OTHER
Responsible Party
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Principal Investigators
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Dolores Wolfram-Raunicher, Dr.
Role: PRINCIPAL_INVESTIGATOR
Medical University of Innsbruck, Department for Plastic Surgery
Locations
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Medical University of Innsbruck, Department for Plastic, Aethetic and Reconstructive Surgery
Innsbruck, Tyrol, Austria
Countries
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References
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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.
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.
Related Links
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Other Identifiers
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EIT2020
Identifier Type: -
Identifier Source: org_study_id
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