Capsular Contracture Associated With ImplantNCT05648929
Experimental and Clinical Investigation of the Implant Surface Roughness Reduction Effect on Early-stage Fibrosis
A study testing Patient Satisfaction Questionnaire, Pregnancy test and Blood draw in people with Capsular Contracture Associated With Implant and Foreign-Body Reaction, run by Medical University Innsbruck at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Capsular Contracture Associated With Implant, Foreign-Body Reaction, Wounds and Injuries
- What is being tested?
- Patient Satisfaction Questionnaire, Pregnancy test and Blood draw
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteAustria
- Study dates
- 20 Jan 2021to 13 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Innsbruck, Department for Plastic, Aethetic and Reconstructive Surgery
Innsbruck, Tyrol, 6020
About this study
Official title: Immunological Analysis of Capsular Tissue Formed Around Expanders With Varying Surface Topography in Women Undergoing Bilateral Nipple or Skin Sparing Mastectomy
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).
Read the detailed description
Expander Immunology trial is a single-center, randomized double-blinded trial. A total of 14 patients, undergoing prophylactic bilateral simultaneous NSME (nipple sparing mastectomy) and implant based breast reconstruction, will receive either SmoothSilk® (Motiva Flora) or other routinely used expander (Mentor CPX™4), randomised to left or right breast after mastectomy. Patient and laboratory expert will be double-blinded. Clinical follow-up visits will be scheduled at 2, 4, 5, 6, 7, 8 and 16 weeks post procedure. Biological sample collection of wound bed fluid will take place daily from day 1 to 5 after expander implantation. Ultrasound will be performed -28 to-1 day before re-operation. Capsule tissue will be harvested and blood draw will be performed during re-operation between 24 to 28 weeks after initial expander implantation.
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:
- 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?
- Does the immune cell profile differ within the capsular tissue formed around conventional expanders versus SmoothSilk® (Motiva) expanders?
- 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?
- Does the cellular composition (histology) show different distribution patterns of immune cells and ECM proteins in these capsules?
- 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)
- 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?
- 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
- Capsular Contracture Associated With Implant, Foreign-Body Reaction, Wounds and Injuries, Tissue Expander Disorder
- Being tested
- Patient Satisfaction Questionnaire, Pregnancy test, Blood draw, Expander based breast reconstruction, Ultrasound of breast
- 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
- Medical subject headings
- Foreign-Body Reaction, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Satisfaction QuestionnaireOther
During regular clinical examinations patient will go through a short questionnaire at week 4, 16 and 24 to check patient satisfaction with expanders
Pregnancy testDiagnostic test
Pre-op; to sufficiently check pregnancy as exclusion criteria
Blood drawProcedure or surgery
pre- expander implantation, alongside anaesthesia pre- expander explantation and exchange with definite implant alongside anaesthesia - no additional vein irritation needed
Expander based breast reconstructionProcedure or surgery
implantation of 2 different expanders intraindividually
Ultrasound of breastProcedure or surgery
Measurement of capsular thickness pre- expander removal
S(AE )monitoringOther
(S)AE evaluation will be performed from Visit 1 (Day 0 = Expander implantation) to Visit 15 (Day 168-196 = Reoperation) according to visit plan.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Patient Satisfaction Questionnaire; Diagnostic Test: Pregnancy test; Procedure: Blood draw; Procedure: Expander based breast reconstruction; Procedure: Ultrasound of breast; Other: S(AE )monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 to 5 days post expander implantation
Secondary outcomes (5)
Intracapsular immune cell composition
After 6-8 months, collected capsular tissue formed around both expanders will be analyzed for immune cell profile and composition by flow cytometry
Measured: At reoperation; 6-8 months post expander implantation
Clinical evaluation of aesthetic outcome and postoperative complications
In follow-up visits 2, 4, and 16 W post-expander implantation; Breast will be clinically evaluated for symmetry and complications through clinical evaluation by the senior surgeon.
Measured: 2, 4 and 16 weeks and at reoperation; 6-8 months post expander implantation
Intracapsular immune cell activity
After 6-8 months, collected capsular tissue formed around both expanders will be analyzed for immune cell activity and cytokine secretion and expression by qPCR
Measured: At reoperation; 6-8 months post expander implantation
Ultrasound evaluation of capsular thickness and postoperative complications
Directly before the expanders are exchanged (6-8 months post implantation), an experienced radiologist will perform non-invasive ultrasound evaluation of capsular thickness and seroma formation.At last cosmetic outcome will be evaluated (breast symmetry, nipple areola complex).
Measured: At reoperation; 6-8 months post expander implantation
Expander Satisfaction and comfortability evaluation by Questionnaire
Directly before the expanders are exchanged (6-8 months post implantation),, and expander comfortability as well as practicability during filling and expansion will be evaluated by the patient and senior surgeon on a scale from 0 to 10.
Measured: At reoperation; 6-8 months post expander implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start20 Jan 2021
- Primary completion1 Jan 2024
- Study completion13 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Capsular Contracture Associated With ImplantStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- intraindividual comparative analysis of two different devices implanted within one individual patient.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dolores Wolfram-Raunicher, Dr., Principal investigator, Medical University of Innsbruck, Department for Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648929
- Sponsor's protocol ID
- EIT2020
- Status last verified
- Jan 2024
- First submitted
- 10 Nov 2022
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The sponsor Medical University Innsbruck and Principal investigator Assoc. Prof. PD. Dr. Wolfram intent to publish the results of this clinical investigation. The ownership of the data shall at all times be held by Medical University Innsbruck and the PI, who will be the main author of all publications by this trial. For the avoidance of doubt, positive and negative results may be published.
Publications
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.
PubMed 36835850Schoberleitner 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.
PubMed 36830674
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Analysis of Capsular Tissue Formed Around Expanders With Varying Surface Topography in Women Undergoing Bilateral Nipple or Skin Sparing Mastectomy
- ClinicalTrials.gov ID
- NCT05648929
- Acronym / sponsor ID
- EIT2020
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 13 Feb 2024 (actual)
- First posted
- 13 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Expander Immunology trial is a single-center, randomized double-blinded trial. A total of 14 patients, undergoing prophylactic bilateral simultaneous NSME (nipple sparing mastectomy) and implant based breast reconstruction, will receive either SmoothSilk® (Motiva Flora) or other routinely used expander (Mentor CPX™4), randomised to left or right breast after mastectomy. Patient and laboratory expert will be double-blinded. Clinical follow-up visits will be scheduled at 2, 4, 5, 6, 7, 8 and 16 weeks post procedure. Biological sample collection of wound bed fluid will take place daily from day 1 to 5 after expander implantation. Ultrasound will be performed -28 to-1 day before re-operation. Capsule tissue will be harvested and blood draw will be performed during re-operation between 24 to 28 weeks after initial expander implantation.
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:
- 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?
- Does the immune cell profile differ within the capsular tissue formed around conventional expanders versus SmoothSilk® (Motiva) expanders?
- 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?
- Does the cellular composition (histology) show different distribution patterns of immune cells and ECM proteins in these capsules?
- 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)
- 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?
- 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)?
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- intraindividual comparative analysis of two different devices implanted within one individual patient.
| Arm | Type | Receives |
|---|---|---|
| the conventional expander Mentor CPX4 (MENTOR) | Active comparator | Other: Patient Satisfaction Questionnaire, Diagnostic Test: Pregnancy test, Procedure: Blood draw, Procedure: Expander based breast reconstruction, Procedure: Ultrasound of breast, Other: S(AE )monitoringintraindividual 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 |
| the expander SmoothSilk(Motiva) with reduced surface roughness | Active comparator | Other: Patient Satisfaction Questionnaire, Diagnostic Test: Pregnancy test, Procedure: Blood draw, Procedure: Expander based breast reconstruction, Procedure: Ultrasound of breast, Other: S(AE )monitoringintraindividual 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Satisfaction QuestionnaireDuring regular clinical examinations patient will go through a short questionnaire at week 4, 16 and 24 to check patient satisfaction with expanders | Other | the conventional expander Mentor CPX4 (MENTOR), the expander SmoothSilk(Motiva) with reduced surface roughness |
| Pregnancy testPre-op; to sufficiently check pregnancy as exclusion criteria | Diagnostic test | the conventional expander Mentor CPX4 (MENTOR), the expander SmoothSilk(Motiva) with reduced surface roughness |
| Blood drawpre- expander implantation, alongside anaesthesia pre- expander explantation and exchange with definite implant alongside anaesthesia - no additional vein irritation needed | Procedure or surgery | the conventional expander Mentor CPX4 (MENTOR), the expander SmoothSilk(Motiva) with reduced surface roughness |
| Expander based breast reconstructionimplantation of 2 different expanders intraindividually | Procedure or surgery | the conventional expander Mentor CPX4 (MENTOR), the expander SmoothSilk(Motiva) with reduced surface roughness |
| Ultrasound of breastMeasurement of capsular thickness pre- expander removal | Procedure or surgery | the conventional expander Mentor CPX4 (MENTOR), the expander SmoothSilk(Motiva) with reduced surface roughness |
| 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. | Other | the conventional expander Mentor CPX4 (MENTOR), the expander SmoothSilk(Motiva) with reduced surface roughness |
Primary outcome
wound bed fluid Immune cell profile (composition)
Time frame: 1 to 5 days post expander implantation
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
wound bed fluid wound proteome composition
Time frame: 1 to 5 days post expander implantation
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
wound bed fluid Immune cell activity
Time frame: 1 to 5 days post expander implantation
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
wound bed fluid wound microbiome composition
Time frame: 1 to 5 days post expander implantation
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
5 secondary outcomes
Intracapsular immune cell composition
Time frame: At reoperation; 6-8 months post expander implantation
Clinical evaluation of aesthetic outcome and postoperative complications
Time frame: 2, 4 and 16 weeks and at reoperation; 6-8 months post expander implantation
Intracapsular immune cell activity
Time frame: At reoperation; 6-8 months post expander implantation
Ultrasound evaluation of capsular thickness and postoperative complications
Time frame: At reoperation; 6-8 months post expander implantation
Expander Satisfaction and comfortability evaluation by Questionnaire
Time frame: At reoperation; 6-8 months post expander implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Results publication: PubMed 36835850Schoberleitner 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.
- Results publication: PubMed 36830674Schoberleitner 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.
- Results referenceLink provided by the sponsor.
- Results referenceLink provided by the sponsor.
- Individual participant dataSharing planned: No. The sponsor Medical University Innsbruck and Principal investigator Assoc. Prof. PD. Dr. Wolfram intent to publish the results of this clinical investigation. The ownership of the data shall at all times be held by Medical University Innsbruck and the PI, who will be the main author of all publications by this trial. For the avoidance of doubt, positive and negative results may be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dolores Wolfram-Raunicher, Dr. principal investigator
Medical University of Innsbruck, Department for Plastic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Satisfaction Questionnaire, Pregnancy test and Blood draw in people with Capsular Contracture Associated With Implant and Foreign-Body Reaction, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound bed fluid Immune cell profile (composition) (time frame: 1 to 5 days post expander implantation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05648929, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.