Immunological Analysis of Capsular Tissue Formed Around Expanders With Varying Surface Topography in Women Undergoing Bilateral Nipple or Skin Sparing Mastectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- wound bed fluid Immune cell activity
研究概览
简要总结
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).
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
- •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.
结局指标
主要结局
wound bed fluid Immune cell activity
时间窗: 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
时间窗: 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
wound bed fluid Immune cell profile (composition)
时间窗: 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
时间窗: 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
次要结局
- Intracapsular immune cell composition(At reoperation; 6-8 months post expander implantation)
- Expander Satisfaction and comfortability evaluation by Questionnaire(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)