Clinical trials: Breast Implant; Complications
Breast Implant Complication, Breast Implant Shell Defect
Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Breast Implant Shell Fissure
This prospective implant-surveillance cohort will evaluate predictors of breast implant shell fissure. Women with aesthetic implants without baseline fissure or rupture will undergo annual clinical and imaging assessment for up…
- Trial name
- NCT07810257
- Testing
- Breast Implant Exposure, Structured Implant Shell Imaging
- Where
- Colombia
- Volunteers
- 3,000 people
- Sponsor
- Research Inc
Implant Complication, Implant Infection
Local Antibiotics for Breast Implants
The BREAST-AB Trial is a multi-center, randomized, double blind, placebo-controlled trial investigating the efficacy of local application of gentamicin, vancomycin and cefazolin in decreasing all-cause implant explantation after…
- Conditions
- Implant Complication, Implant Infection, Implant Site Infection, Implant Capsular Contracture
- Trial name
- BREAST-AB (NCT04731025)
- Testing
- Gentamicin, Cefazolin and Vancomycin
- Where
- 8 sites in Denmark
- Volunteers
- 1,003 people, healthy volunteers welcome
- Sponsor
- Mikkel Herly
Capsular Contracture, Implant
Ultrasound Guided Treatment of Steroids for Capsular Contracture in Patients With Reconstructed/Augmented Breast
Ultrasound guided treatment of steroids for capsular contracture in patients with reconstructed/augmented breast
- Trial name
- NCT03171974
- Testing
- Dexamethasone, US
- Where
- Israel
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Rabin Medical Center
Breast Implant; Complications, Breast Implantation; Methods, Safety and Performance
Safety and Performance of Motiva® Sizers
The Motiva® Sizer clinical study is a four-year, multicenter, post-marketing, and cohort study, designed to confirm the safety and performance of Motiva® Sizer in breast augmentation or reconstruction procedures.
- Conditions
- Breast Implant; Complications, Breast Implantation; Methods, Safety and Performance, Mammaplasty, Breast Reconstruction
- Trial name
- NCT06274736
- Testing
- Motiva Sizer
- Where
- Costa Rica
- Volunteers
- 133 people, healthy volunteers welcome
- Sponsor
- Establishment Labs
Bacterial Infection, Anti-infective Agents
Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction
Antibiotics are used routinely in postoperative tissue expander based breast reconstruction (TE) and autologous flap (AF) breast reconstruction procedures.
- Conditions
- Bacterial Infection, Anti-infective Agents, Breast Implantation
- Trial name
- NCT01244698
- Testing
- Cefadroxil discontinued early, Cefadroxil until drain removal
- Where
- United States
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- Stony Brook University
Solid Tumor
A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients With Advanced Solid Tumors.
This was a clinical study with an orally administered drug, BDTX-189 in participants with advanced solid tumors that had select mutations or alterations in human epidermal growth factor receptor 2 (HER2/ErbB2) genes or epidermal…
- Trial name
- MasterKey-01 (NCT04209465)
- Testing
- BDTX-189
- Where
- 38 sites in United States, Denmark and 2 more
- Volunteers
- 91 people
- Sponsor
- Black Diamond Therapeutics, Inc.
Breast Implant; Complications, Infection or Inflammation
Molecular Mechanisms Associated With Breast Implant Complications
Bacterial biofilms cause implant failures, chronic inflammation, and immune polarization. The study investigates the possible role of bacterial biofilm as a factor in the etiology of Breast Implant Illness.
- Trial name
- MMABIC (NCT05736354)
- Where
- 3 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Indiana University
Breast Implant-Associated Anaplastic Large Cell Lymphoma, Capsular Contracture, Implant
Breast-implant ASsocIated anaplastIc Large Cell Lymphoma and CApsular Contracture
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…
- Conditions
- Breast Implant-Associated Anaplastic Large Cell Lymphoma, Capsular Contracture, Implant, Breast Implant; Complications
- Trial name
- BASILICA (NCT05017337)
- Where
- 2 sites in United Kingdom
- Volunteers
- 100 people
- Sponsor
- Royal Marsden NHS Foundation Trust
Breast Implant; Complications, Breast Implant Protrusion
Standard Silicone-based vs. B-Lite® Light Weight Breast Implant After Total Mastectomy and Radiotherapy for Breast Cancer
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…
- Conditions
- Breast Implant; Complications, Breast Implant Protrusion, Breast Cancer, Radiotherapy Side Effect
- Trial name
- BLITE-01 (NCT03737500)
- Testing
- B-Lite® light weight breast implant, Standard silicone-based breast implant
- Where
- Italy
- Volunteers
- 49 people
- Sponsor
- Istituti Clinici Scientifici Maugeri SpA
Complications; Contraceptive, Female Lactation
Early Versus Standard Postpartum Insertion of the Etonogestrel Contraceptive Implant
A highly effective single rod contraceptive implant is now available for use in the US. Delays in the insertion of the device until later in the postpartum period may negatively impact initiation rates.
- Trial name
- NCT00847587
- Testing
- Etonogestrel contraceptive implant
- Where
- United States
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- University of Utah
Breast Cancer, Mastectomy
Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer
The goal of this clinical trial is to learn if the AMADeuS care pathway is as safe as usual hospital care and works as well for pain control in women having mastectomy with immediate prepectoral breast reconstruction.
- Conditions
- Breast Cancer, Mastectomy, Prepectoral Breast Reconstruction, ERAS Programmes
- Trial name
- AMADeuS (NCT07510698)
- Testing
- AMADeuS Perioperative Pathway, Usual Perioperative Care
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- University of Rome Tor Vergata
Surgical Site Infection
Dressing Wear Time After Breast Augmentation With Prosthesis
This study was designed to determine whether the duration of dressing wear following augmentation mammaplasty influence skin colonization and eventually surgical site infections rates.
- Trial name
- NCT01553604
- Testing
- augmentation mammaplasty
- Where
- Brazil
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Daniela Francescato Veiga
Seroma, Breast Cancer
Seroma of the Mammary Gland
The study is designed as international, prospective, minimal interventional study in cooperation with EUBREAST e.V. (European Breast Cancer Research Association of Surgical Trialists).
- Conditions
- Seroma, Breast Cancer, Mastectomy, Breast Implant; Complications
- Trial name
- SerMa (NCT05899387)
- Testing
- Swap collection, Seroma punction, Blood sampling
- Where
- Germany
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- University Hospital Augsburg
Breast Implant; Complications, Infection or Inflammation
Histological Analysis of AlloMend® Acellular Dermal Matrix Used in Breast Implant Surgeries
This is a prospective, histologic analysis of biopsied tissue obtained from participants who have undergone a pre-pectoral breast reconstruction or augmentation surgery with expander placement and AlloMend® Acellular Dermal…
- Trial name
- NCT05744414
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- AlloSource
Breast Implant; Complications, Quality of Life
An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants With Smooth Surface
The study investigates the safety and performance of Silimed® brand smooth surface breast implants in women born with indication for primary and secondary (revision) augmentation to be followed up for 10 years.
- Conditions
- Breast Implant; Complications, Quality of Life, Satisfaction, Safety and Performance
- Trial name
- STEPS S (NCT05345821)
- Where
- Brazil
- Volunteers
- 384 people, healthy volunteers welcome
- Sponsor
- Silimed Industria de Implantes Ltda
Breast Implant Rupture, Breast Implant; Complications
Prospective Observational Clinical Follow-up of Euromi Biosciences Pre-filled Silicone Gel Breast Implants
Prospective observational clinical follow-up of Euromi Biosciences silicone gel-filled breast implants - Post-market clinical investigation - ELEGANT
- Trial name
- ELEGANT (NCT05987475)
- Testing
- Breast reconstruction
- Where
- France
- Volunteers
- 177 people, healthy volunteers welcome
- Sponsor
- Euromi Biosciences
Breast Cancer, Breast Implant; Complications
Association of Silicone Breast Implants With Overall Wellbeingand Auto-immune Diseases
Background: Implant-based breast reconstructions contribute considerably to the quality of life of breast cancer patients. A knowledge gap exists concerning the potential role of breast implants in the development of so called…
- Conditions
- Breast Cancer, Breast Implant; Complications, Autoimmune Diseases
- Trial name
- AREOLA-B (NCT05400954)
- Testing
- Breast reconstruction with silicone breast implant, Breast conserving surgery/Mastectomy/Autologous reconstruction, Breast Augmentation
- Where
- 7 sites in Netherlands
- Volunteers
- 15,000 people
- Sponsor
- The Netherlands Cancer Institute
Complications; Breast Prosthesis, Infection or Inflammation
Antibiotics and Tissue Expanders in Breast Reconstruction
This study is a randomized controlled non-blinded double arm study examining the effect of routine postoperative oral antibiotic therapy in preventing postoperative surgical site infections after breast reconstruction.
- Trial name
- NCT01899690
- Testing
- antibiotic
- Sponsor
- Emory University
Surgery Date, Age
Quality of Life of Patients Who Have Undergone Bilateral Mastectomy
The investigators therefore aim to determine whether the type of mastectomy (preventive in a high-risk patient or therapeutic in a patient with a history of cancer), as well as the timing (immediate or delayed) and type of breast…
- Conditions
- Surgery Date, Age, BMI, Height
- Trial name
- RM BREAST Q (NCT07699913)
- Volunteers
- 115 people
- Sponsor
- University Hospital, Grenoble
Complications, Postoperative/Perioperative, Quality of Life
Complications and Long-term Satisfaction in Autologous vs. Implant-Based Breast Reconstruction
Current literature on complications and health-related quality of life in autologous and alloplastic breast reconstruction is inconclusive.
- Conditions
- Complications, Postoperative/Perioperative, Quality of Life, Satisfaction, Patient
- Trial name
- NCT06295042
- Testing
- BREAST-Q Questionnaire
- Where
- Austria
- Volunteers
- 162 people, healthy volunteers welcome
- Sponsor
- Medical University of Graz