Infections

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Musculoskeletal Diseases

Nervous System Diseases

Wounds and Injuries

Breast Neoplasms

Communicable Diseases

Contracture

Seroma

Implant Capsular Contracture

Joint Diseases

Muscular Diseases

Inflammation

Foreign Bodies

Foreign-Body Reaction

Prosthesis Failure

Postoperative Complications

Native adm used in the setting of mastectomy and implant reconstruction after QUART

Veritas adm used in the setting of mastectomy and implant reconstruction after QUART

Native adm used in the setting of expander removal and implant positioning after mastectomy + RT

Veritas adm used in the setting of expander removal and implant positioning after mastectomy + RT

Native adm used in the setting of implant exchange after mastectomy + RT

Veritas adm used in the setting of implant exchange after mastectomy + RT

Native adm used in the setting of implant exchange after QUART+ Mastectomy and implant reconstruction

Veritas adm used in the setting of implant exchange after QUART+ Mastectomy and implant reconstruction

acellular dermal matrix implant in implant-based breast reconstruction in patients receiving radiotherapy

acellular dermal matrix implant for breast reconstruction

Andrea Vittorio Emanuele Lisa, MD

The goal of this retrospective observational trial is to compare two different devices, used in implant-based breast reconstruction, called acellular dermal matrices, which are a sort of collagen patch that integrates with the tissues of the patient and helps in contrasting the collateral effects of radiotherapy (capsular contracture, implant loss)

The main questions the study aims to answer are:

* is one of the two matrices better than the other? (better results with fewer complications)
* is there a group of patients who benefit more than another from the use of this type of devices?
* is there an adm which works better in one specific subgroup of patients? Participants have undergone mastectomy, radiotherapy and implant reconstruction with the aid of two different kinds of acellular dermal matrices.

Researchers will compare patients who receive the porcine-derived adm and the patients who receive bovine-derived adm to see if there is a difference in terms of capsular contracture reduction, aestethic result and complications.

Radiotherapy is highly effective in breast cancer treatment, yet it impairs satisfactory implant-based reconstruction, due to high rates of capsular contracture and implant loss. This said, a fervent investigtion exists upon solutions that can make implant-based reconstruction safer and aesthetically satisfying, including the use of acellular dermal matrices. We retrospectively want to analyze our ADM-assisted post-RT implant-based breast reconstructions comparing two different matrices (porcine and bovine), when autologous reconstruction was contraindicated, to assess eventual differences in efficacy and risk profile of the devices. We want to further stratify the population in 4 groups based on clinical presentation to assess if there was a group where ADMs proves to perform better (Group A - previous quadrantectomy, Group B - previous mastectomy and expander reconstruction, Group C - previous mastectomy and implant reconstruction, Group D - prior quadrantectomy followed by mastectomy and implant reconstruction).

female patients undergoing breast reconstruction after mastectomy

Comparative Analysis of Two Animal-derived ADMs in Irradiated Implant-based Reconstruction

Comparative Study of the Efficacy and Risk Profile of Two Animal-derived Acellular Dermal Matrices in Patients Undergoing Mastectomy, Radiotherapy and Implant-based Reconstruction

Is there a type of dermal matrix that performs better than the other in a specific subgroup of patients?

Does one dermal matrix perform better than the other in terms of efficacy and complication rates?

Is there a subgroup of patient where the use of ADM proves more beneficial than others?

European Institute of Oncology

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma

Lymphoma, Large-Cell, Anaplastic

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, T-Cell

Lymphosarcoma

Anaplastic Large Cell Lymphoma

Breast implant associated anaplastic large cell lymphoma (BIA-ALCL) patients recruited both retrospectively and prospectively.

Pre- and post-operative (3m and 12m) blood samples taken from prospectively recruited patients. Patients undergoing surgery + neo-adjuvant chemotherapy will be invited to donate an additional blood sample following the end of their neo-adjuvant chemotherapy.

Diagnostic pathology: Where possible fresh seroma aspirate / capsular tissue will be obtained, if not possible the FFPE embedded seroma or tissue block will be requested.

Post-operative pathological FFPE tissue samples obtained from all recruited patients.

Patients undergoing capsule related surgery (any-grade of capsular contracture, irradiated and unirradiated capsules) recruited prospectively.

Pre- and post-operative (3m) blood samples taken from all patients. Intra-operative tissue sampling (capsular washings, 2 samples of ADM and 2 samples of non-ADM capsule) from all patients.

Implant naive patients undergoing implant insertion surgery recruited prospectively.

Pre- and post-operative (3m and 12 m) blood samples taken from all patients.

Joseph Ward, MBChB MRCS

Aadil Khan, FRCS (Plast)

Ann Gandolfi

Aadil Khan, FRCS(Plast)

BASILICA is a UK NIHR Biomedical Research Centre funded study recruiting patients at The Royal Marsden NHS Foundation Trust. The study aims to obtain blood and tissue samples from patients with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), capsular contracture and implant-naïve patients undergoing primary implant insertion surgery for translational scientific analysis.

BASILICA is a translational research study being undertaken at The Royal Marsden NHS Foundation Trust that aims to investigate aetiology of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), capsular contracture (CC) as well as the immune changes that occur in implant-naïve patients undergoing primary implant insertion surgery.

BIA-ALCL is a rare tumour seen in a very small number of women with textured breast implants. Overall incidence is estimated at 2 per 1,000,000 women/year with a lifetime risk of 1 in 30,000 for textured breast implants. It presents commonly with a sudden seroma around an implant or, occasionally, as a soft tissue mass adjacent to the implant capsule. In 2016, the disease was classified by the WHO as a CD30+ ALK- non-Hodgkin's T-cell lymphoma. Surgery (en bloc capsulectomy) is curative for the majority of cases. Scientific appreciation of aetiology is limited but current thinking implicates chronic inflammation as a protagonist for pathogenesis through hypertonic antigen presentation.

CC is the fibrotic tightening of a capsule that forms around a breast implant and leads to palpable hardening, pain and visible distortion. The biggest risk factor is radiotherapy with quoted incidence rates as high as 50% in some series. Management is a significant clinical challenge with limited options and high recurrence rates. The most common surgical approaches are to remove the capsule (capsulectomy) or exchange and change the anatomical plane of implant placement. The only definitive surgical management is to explant the implant and perform autologous breast reconstruction, if feasible, or, no reconstruction at all.

BASILICA will obtain pathological capsular tissue (CC and BIA-ALCL) and non-pathological capsule tissue (control tissue) as well as blood samples from patients undergoing any form of implant-related surgery. The investigators aim to use these tissues to perform translational analyses investigating the aetiology of each pathology and the physiological immunological response to silicone implant insertion. They hypothesise that 1) specific differences exist in the immunological and matrisomal profiles of CC and BIA-ALCL that drive the pathogenesis of each clinical entity, and that 2) insertion of a silicone prosthesis causes changes in the composition of the humoral and cellular components of the circulating immune system.

Pre- and post-operative blood samples (BASILICA-A prospective, BASILICA-C, BASILICA-N); Capsular tissue samples (BASILICA-C: intra-operative tissue sampling, BASILICA-A retrospective: pathological FFPE blocks); Capsular Washings (BASILICA-C only)

Breast-implant ASsocIated anaplastIc Large Cell Lymphoma and CApsular Contracture

A Translational Study of Breast-implant assocIated anaplastIc Large Cell Lymphoma and Capsular Contracture

Non-identifiable patient and translational scientific data may be shared on request with trusted scientific partners.

Perform immunohistochemical profiling of capsular tissues (CC, BIA-ALCL and control) and seroma fluid for immune cell subtypes to determine if differences exist within and between groups (BASILICA A and C).

Perform multi-OMIC (methylome, transcriptome, proteome) profiling of capsular tissues (CC, BIA-ALCL and control) to determine if differences exist within and between groups (BASILICA A and C).

Perform immune profiling of peripheral blood mononuclear cells from BIA-ALCL and Non-BIA-ALCL donors (CC and implant naive) to determine if differences exist within and between groups (BASILICA A, C and N)

Correlate demographic and clinical characteristics of biobank donors with translational scientific dataset (BASILICA A, C and N)

Royal Marsden NHS Foundation Trust

Breast Diseases

Skin Diseases

Primary Surgery: Skin sparing mastectomy (nipple sparing if appropriate) and axillary surgery according to guidelines or protocol. Reconstruction with silicone implant or expander covered by pectoral muscle and mesh or matrix.

Delayed reconstruction: Final reconstruction with any reconstructive procedure - being it autologous or implant-based (one- or two-stage, +/- acellular dermal matrix (ADM)) - is performed 6-12 months after completion of chemotherapy and PMRT. Any contralateral procedure is allowed when doing the delayed surgery, but not in relation to the initial cancer surgery.

Primary surgery: Total mastectomy and axillary surgery according to guidelines or protocol.

Delayed reconstruction: 6-12 months after completion of PMRT: final recon-struction with any reconstructive procedure - being it autologous or implant-based (one-or two-stage, +/- ADM). Any contralateral procedure is allowed at any time point after PMRT has been delivered This arm has been closed nov 2023

Skin sparing mastectomy and reconstruction with silicone implant or expander covered by pectoral muscle and mesh or matrix. Final reconstruction with any reconstructive procedure 6-12 months after completion of chemotherapy and RT.

Delayed-immediate reconstruction

Total mastectomy and delayed reconstruction:with any reconstructive procedure 6-12 months after completion of PMRT

Delayed reconstruction

Tove F Tvedskov, DMSc

Peer M Christiansen, Professor

Tove Tvedskov

Rikke Bredgaard

Lisbeth Hölmich

Lone Bak Hansen

Tine Damsgaard, Professor

Birgitte V Offersen, Professor

Peer Christiansen, Professor

Majbrit Jensen, MSc

In breast cancer patients treated by mastectomy and adjuvant post-mastectomy radiation therapy (PMRT) reconstruction is often delayed until 6 - 12 month after completion of chemotherapy and PMRT, due to high risk of complication. In this trial the safety of the delayed-immediate reconstruction method is tested, where a skin sparing mastectomy and reconstruction with silicone implant is performed at primary surgery to save the native skin for the final delayed reconstruction.

An increasing proportion of breast cancer patients treated by mastectomy wish for a breast reconstruction. If post-mastectomy radiation therapy is recommended, the reconstruction is often delayed until 6 - 12 months after completion of chemotherapy and radiation therapy due to risk of complication that might delay adjuvant treatment. At this time the native skin over the removed breast cannot be used in the reconstruction, resulting in a suboptimal aesthetic outcome. In the delayed-immediate reconstruction method, a skin sparing mastectomy and reconstruction with implant is performed at primary surgery, to save the native skin under radiation therapy, thereby improving the chance for a good aesthetic outcome at the final delayed reconstruction. In this trial breast cancer patients treated by mastectomy and loco-regional radiation therapy is randomized to either delayed reconstruction or delayed-immediate reconstruction. The complication rate as well as morbidity, aesthetic outcome and psychological well-being after delayed-immediate reconstruction will be compared with delayed reconstruction

The study started as a randomized trial but was november 2023 changed for a prospective single arm tieal

Delayed-immediate Versus Delayed Breast Reconstruction in Breast Cancer Patients With Mastectomy and Radiation Therapy

The DBCG RT Recon Trial: Delayed-immediate Versus Delayed Breast Reconstruction in Early Breast Cancer Patients Treated With Mastectomy and Adjuvant Loco-regional Radiation Therapy. A Multicenter Randomized and Single Arm Clinical Trial

Number of patients with complication deeming surgical intervention necessary (excluding percutaneous drainage and antibiotic treatment for inflammation in cases without need for open drainage):

* Infection
* Hematoma
* Loss of implant/expander
* Necrosis
* Seroma

Number of patients with complication (Infection with need for antibiotics and/or necrosis) without intervention necessary

Degree of Depression measured by Becks Depression Inventory, BDII using a scale from 1 to 4, 4 being the worst

Fear of cancer recurrence measured by Concerns About Recurrence Questionnaire-3 (CARQ-3 ) on a scale from 1 to 10, 10 worst (fear all the time)

Patient satisfaction and QoL measures by the BREAST-Q-instruments on a scale from 1 to 5, 5 being worst

Time from primary surgery to start of adjuvant therapy

Patient reported morbidity measured by a questionnaire. The prevalence of pain will be assessed on a 0-10 numerical rating scale (NRS) and reported as: 'light pain' NRS 1-3; 'moderate pain' NRS 4-6; and 'severe pain' NRS 7-10. Sensory disturbances will be assessed by a dichotomous 'yes/no' question,. Lymphoedema will be assessed on a 0-10 numerical rating scale, 10 being worst. Body image will be assessed on a 0-7 numerical rating scale, 7 being best.

Difference in arm circumference between arms 15 cm/10 cm proximal/distal to the olecranon bilaterally. Any difference ≥10% defines lymhoedema.

Differences between arms in range of motion of the shoulder measured at abduction/flexion with the patient sitting in front of a poster with a circle with degrees 0-180˚.Any difference ≥10 degrees defines defines restricted motion

Degree of capsular Contracture using Baker grading

Aesthetic outcome scored bt the physician using breast Photo, on a scale from 0 to 3, 3 being worst

Danish Breast Cancer Cooperative Group

Consultant, DMSc, Phd, associated professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Diseases and Abnormalities at or Before Birth

Syndrome

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hereditary Breast and Ovarian Cancer Syndrome

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

Ovarian Cancer

Ovarian Epithelial Cancer

5 consecutive patients with breast cancer or a breast cancer-causing gene that elect to undergo bilateral breast reconstruction will be Insertion of Tissue Expander with Fluid Reservoir as the first stage of reconstruction. Post-surgical care will be similar as patients with conventional expanders, except that during office visits, fluid will be transcutaneously aspirated from the fluid reservoir on each side.

Use of unique expander type in first stage of a two-stage breast reconstruction, without prolonged drain placement.

Insertion of Tissue Expander with Fluid Reservoir

Edward C Ray, MD

The primary objective of this small feasibility pilot study is to demonstrate that implant-based breast reconstruction (after treatment for cancer) can successfully be performed without prolonged drain placement, using a tissue expander with a reservoir and in-office transcutaneous fluid aspiration. Secondly, the investigators aim to provide enough confidence in this technique that a larger study can be performed to demonstrate fewer complications (infection, drain-related pain and re-operation rates) when compared to the use of conventional tissue expanders and/or implants with prolonged drain placement.

Patients electing to have staged, implant-based, bilateral breast reconstruction at the time of mastectomy (for either cancer or cancer prevention) will undergo a standardized subpectoral tissue expander placement (using the Sientra AlloX2 dual-port device) on each side of the chest with a single piece of acellular dermal matrix (ADM). A single drain in the subcutaneous pocket of each breast will be used and removed on the first post-operative day. Patients will be admitted for overnight observation in the hospital. Each post-operative day fluid will be aspirated from each reservoir port using a standard sterile technique, and the volume recorded. After discharge, patients will be seen in the office within one week of discharge and fluid aspirated from each expander using the reservoir ports, and the volume shall be recorded. The aspiration will be repeated weekly until expansion is completed and/or the amount of fluid aspirated is less than 10 cc.

Patients will be asked to complete a 7 item multiple-choice questionnaire regarding their attitudes about their breast reconstruction, first at completion of tissue expansion and finally at their first follow-up visit following placement of permanent breast implants.

This study utilizes FDA 510k-classified devices that allow removal of fluid without drains, in lieu of more conventional expanders, allowing for the avoidance of prolonged drain usage.

Female breast cancer patients are usually candidates for reconstruction using breast implants

Tissue Expansion in Breast Reconstruction Without Drains

Tissue Expansion in Breast Reconstruction Without Drains: A Study Using a Tissue Expander That Collects Periprosthetic Fluid

The number of patients that successfully complete two stage implant-based breast reconstruction with fluid-reservoir tissue expanders and early drain removal. An outcome failure would be if the expander required removal due to uncontrolled seroma, infection or other factor that prevents a successful implant-based reconstruction.

Sientra, Inc.

Cedars-Sinai Medical Center

Staff Physician II

Women with first diagnosis of breast cancer or DCIS and planned skin-sparing mastectomy and implant placement

Women with first diagnosis of breast cancer or DCIS and planned simple mastectomy

healthy women with high risk for breast cancer and planned bilateral risk-reducing mastectomy and implant reconstruction

healthy women planned for plastic breast implant surgery

Performing the surgery (Mastectomy with or without implant reconstruction; Insertion of Breast implants for control group 3) according to valid standards.

In addition, taking swabs intraoperatively according to protocol from skin and surgical site.

Swap collection

Puncturing of a seroma in case of occurence and clinical need

Seroma punction

Blood sampling at defined time points according to protocol

Blood sampling

Nina Ditsch, Prof.

Melitta Köpke, Dr. med.

Melitta Köpke, Dr.

Thorsten Kühn, Prof.

The study is designed as international, prospective, multicenter non-AMG/MPG study in cooperation with EUBREAST e.V. (European Breast Cancer Research Association of Surgical Trialists). Furthermore, it is planned to initiate a registry for postoperative breast seromas.

Postoperative seroma formations are one of the most common and serious complications after breast surgery, above all after mastectomy. Especially in patients who have opted for breast reconstruction using implants, seromas lead to infections and wound dehiscence which can result in implant and finally breast loss. To date, the cause of seroma development has not yet been clarified. First data of a pilot study of our research group identified an association with immunological-inflammatory processes as a possible cause for seroma development (Seroma after Simple Mastectomy in Breast Cancer-The Role of CD4+ T Helper Cells and the Evidence as a Possible Specific Immune Process; Pochert et al. 2022).

The main objective of the SerMa (Seroma of the Mammary gland) study presented here is to identify patient groups who have an increased risk of developing seromas based on immunological/inflammatory processes. Based on the findings clinical consequences should be developed in the future, such as more precise risk-adapted patient education and individualized advising regarding the selection of the reconstruction procedure, with the goal of minimizing complication rates. In addition, analyses of the tumor and the microenvironment will be performed to differentiate possible carcinoma-specific immunological processes.

* blood
* seroma fluid
* microbiome analysis
* tumor/breast tissue specimen

Seroma of the Mammary Gland

Prospective, International, Multicenter Non-AMG/MPG Study to Detect Possible Markers for Prediction of Seroma Development and Risk Assessment of a Breast Seroma After Skin-sparing Mastectomy and Implant Breast Reconstruction

* Examination of seroma fluid and blood samples to identify immunological markers.
* Local microbiome analyses to investigate a possible bacterial colonization.
* Tissue analyses to determine possible carcinoma-specific immunologic processes.

University Hospital Augsburg

Prof. Dr. med.

Body Weight

Participants candidated to total mastectomy and radiotherapy will receive immediate or delayed breast reconstruction by the use of standard silicone-based breast implant (i.e. the breast implant commonly used in our institution)

Participants candidated to total mastectomy and radiotherapy will receive immediate or delayed breast reconstruction by the use of B-Lite® light weight breast implant

Definitive breast reconstruction after total mastectomy by the use of B-Lite® light weight breast implant

B-Lite® light weight breast implant

Definitive breast reconstruction after total mastectomy by the use of silicone-based breast implants commonly used in our institution

Standard silicone-based breast implant

Fabio Corsi, MD

Reconstructive surgery with breast implants after total mastectomy for breast cancer is invariably related to several possible complications, such as atrophy of surrounding tissues, skin thinning, capsular contracture, wound dehiscence and inframammary fold break. Such complications are promoted by elastic properties of tissues and their response to gravity forces exerted on breast implant weight, leading to microischaemic events. A poor cosmetic outcome may result up to breast implant exposure, and its removal may become necessary, thus compromising the quality of breast reconstruction. These complications are further favoured by post-mastectomy radiotherapy (PMRT), since irradiation could enhance microischaemia of peri-prosthetic soft tissues and muscle, with subsequent inadequate healing, fibrosis and thinning. Since PMRT has been associated to improved loco-regional control in node-positive breast cancer patients, its use has increased in recent years. On one hand, PMRT has improved loco-regional control but, on the other hand, it has increased the failure rate of breast reconstruction after total mastectomy. Change of timing in breast reconstruction (immediate vs. two-staged by use of tissue expander) has not decreased the complications rate after PMRT. Currently the failure rate of breast reconstruction after total mastectomy and PMRT ranges from 0% to 40%. The present study will recruit 80 participants affected by breast cancer candidated to total mastectomy with immediate breast reconstruction and subsequent PMRT or total mastectomy with reconstruction by tissue expander, subsequent PMRT and then definitive reconstruction with breast implant. Participants will be randomized in two experimental arms: 40 patients will receive final reconstruction by the use of standard silicone-based breast implant and the other 40 patients will receive B-Lite® light weight breast implant. Participants will be followed up at 1, 6, 12 and 24 months, and all patients will undergo breast MRI at 6 months. The primary goal of the present study is to evaluate the failure rate of breast reconstruction (i.e. the need of re-intervention for breast implant removal). Secondary end-points include the overall complications rate, MRI evaluation of breast implant and surrounding tissues, cosmetic outcomes and quality of life including participants' satisfaction with breast reconstruction.

Standard Silicone-based vs. B-Lite® Light Weight Breast Implant After Total Mastectomy and Radiotherapy for Breast Cancer

Standard Silicone-based Breast Implant vs. B-Lite® Light Weight Breast Implant for Reconstructive Surgery After Total Mastectomy and Post-Mastectomy Radiotherapy for Breast Cancer: a Randomized Clinical Trial

Need of re-intervention for breast implant removal for any cause (such as breast implant exposure)

Occurrence of any complication at any time point, such as: capsular contracture, wound dehiscence, skin/soft tissues necrosis, inframammary fold break, implant exposure treated conservatively, hematoma, peri-prosthetic fluid collection, wound/implant infection

MRI evaluation for skin/soft tissues thinning, capsular contracture, implant break, chronic seroma

Objective evaluation of cosmetic outcome by jugular-nipple/areola complex (NAC) and NAC-inframammary fold distances to evaluate symmetry, objective evaluation of plastic surgeon with serial photographs

QoL evaluation included patient's satisfaction with breast reconstruction using the Body Image after Breast Cancer Questionnaire (BIBCQ)

QoL evaluation included patient's satisfaction with breast reconstruction, using the BREAST-Q score

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparative Analysis of Two Animal-derived ADMs in Irradiated Implant-based Reconstruction	NCT06139588	Breast Implant;... Breast Implant ... Implant Capsula... Breast Seroma Breast Implant ... Breast Cancer	acellular derma...	-	European Institute of Oncology
Breast-implant ASsocIated anaplastIc Large Cell Lymphoma and CApsular Contracture	NCT05017337	Breast Implant-... Capsular Contra... Breast Implant;...		16 Years - 100 Years	Royal Marsden NHS Foundation Trust
Delayed-immediate Versus Delayed Breast Reconstruction in Breast Cancer Patients With Mastectomy and Radiation Therapy	NCT03730922	Breast Neoplasm... Complication of... Breast Implant;...	Delayed-immedia... Delayed reconst...	18 Years -	Danish Breast Cancer Cooperative Group
Delayed-immediate Versus Delayed Breast Reconstruction in Breast Cancer Patients With Mastectomy and Radiation Therapy	NCT03730922	Breast Neoplasm... Complication of... Breast Implant;...	Delayed-immedia... Delayed reconst...	18 Years -	Danish Breast Cancer Cooperative Group
Tissue Expansion in Breast Reconstruction Without Drains	NCT03784859	Breast Cancer Hereditary Brea... Breast Implant;...	Insertion of Ti...	21 Years -	Cedars-Sinai Medical Center
Seroma of the Mammary Gland	NCT05899387	Seroma Breast Cancer Mastectomy Breast Implant;...	Swap collection Seroma punction Blood sampling	18 Years -	University Hospital Augsburg
Seroma of the Mammary Gland	NCT05899387	Seroma Breast Cancer Mastectomy Breast Implant;...	Swap collection Seroma punction Blood sampling	18 Years -	University Hospital Augsburg
Standard Silicone-based vs. B-Lite® Light Weight Breast Implant After Total Mastectomy and Radiotherapy for Breast Cancer	NCT03737500	Breast Implant;... Breast Implant ... Breast Cancer Radiotherapy Si...	B-Lite® light w... Standard silico...	18 Years - 75 Years	Istituti Clinici Scientifici Maugeri SpA

Spots Global Cancer Trial Database for breast implant; complications