Clinical trials: Breast Implant Infection
Rare Disorders, Undiagnosed Disorders
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
The Coordination of Rare Diseases at Sanford (CoRDS) is an international patient registry that serves as a centralized resource for rare disease research.
- Conditions
- Rare Disorders, Undiagnosed Disorders, Disorders of Unknown Prevalence, Cornelia De Lange Syndrome
- Trial name
- CoRDS (NCT01793168)
- Where
- United States
- Volunteers
- 20,000 people
- Sponsor
- Sanford Health
Breast Cancer, Breast Reconstruction
Implant-based Breast Reconstruction in Post-bariatric Women - a Registry-based National Study
The goal of this national registry-based study is to investigate the prevalence of reconstructive breast surgery and risk factors for surgical complications in women who have had weight loss surgery previously.
- Conditions
- Breast Cancer, Breast Reconstruction, Bariatric Surgery, Breast Implant
- Trial name
- NCT07059104
- Testing
- Breast augmentation, Breast reconstruction after mastectomy
- Where
- Sweden
- Volunteers
- 20,000 people
- Sponsor
- Vastra Gotaland Region
Breast Implant Infection
Infection After Implant-based Breast Reconstruction
Infections following postmastectomy breast reconstruction can compromise surgical outcomes and lead to significant morbidity. The aim of this study was to determine factors associated with infection following two-stage…
- Trial name
- NCT06187649
- Testing
- breast reconstruction
- Volunteers
- 5,000 people
- Sponsor
- Seoul National University Hospital
Breast Implant; Complications, Breast Implant Infection
Comparative Analysis of Two Animal-derived ADMs in Irradiated Implant-based Reconstruction
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…
- Conditions
- Breast Implant; Complications, Breast Implant Infection, Implant Capsular Contracture, Breast Seroma
- Trial name
- RTADM (NCT06139588)
- Testing
- acellular dermal matrix implant for breast reconstruction
- Where
- Italy
- Volunteers
- 146 people
- Sponsor
- European Institute of Oncology
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
Mastectomy, Infections
Reusable Versus Disposable Draping System in Breast Reconstruction Surgery
This study will look at the rate of infections developed by subjects comparing the use of disposable draping systems versus reusable draping systems in the operating room.
- Conditions
- Mastectomy, Infections, Breast Reconstruction
- Trial name
- NCT01176786
- Testing
- Culture Swabs, Rodac Plate Cultures
- Where
- United States
- Volunteers
- 107 people
- Sponsor
- Wake Forest University Health Sciences
Implants, Breast
Sonication of Explanted Breast Implants for Detection of Subclinical Infection
Objective. Capsular contracture is a frequent complication after breast implantation with unclear etiology. Summary Background Data: Microorganisms may trigger chronic periimplant inflammation with subsequent capsular fibrosis.
- Trial name
- NCT01138891
- Volunteers
- 121 people
- Sponsor
- Centre Hospitalier Universitaire Vaudois
Surgical Site Infection, Capsular Contracture Associated With Breast Implant
Postoperative Antibiotics Following Primary and Secondary Breast Augmentation
Postoperative antibiotics are routinely used for implant-based breast augmentation at the investigators' institution. From 2017-2019, the investigators' institution has conducted approximately 270 primary and secondary breast…
- Conditions
- Surgical Site Infection, Capsular Contracture Associated With Breast Implant, Antibiotic Resistant Infection, Antibiotic Side Effect
- Trial name
- NCT04834310
- Testing
- Cefazolin, Cephalexin
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
T-cell Lymphoma, NK-Cell Lymphoma
A Registry for People With T-cell Lymphoma
The purpose of this registry study is to create a database-a collection of information-for better understanding T-cell lymphoma.
- Conditions
- T-cell Lymphoma, NK-Cell Lymphoma, T-cell Prolymphocytic Leukemia, T-cell Large Granular Lymphocytic Leukemia
- Trial name
- NCT05978141
- Testing
- Optional Blood Sample and Nail Sample
- Where
- 26 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Surgical Site Infection, Surgical Complication
A Novel Surgical Irrigation Solution in Post-Mastectomy Reconstruction: Evaluating Xperience™
Goal of the Clinical Trial: The purpose of this clinical trial is to learn whether Xperience™ surgical irrigation solution is more effective than a standard dilute povidone-iodine solution in reducing surgical site infections…
- Conditions
- Surgical Site Infection, Surgical Complication, Implant Infection, Implant Complication
- Trial name
- NCT06649890
- Testing
- Xperience™ Advanced Surgical Irrigation, Dilute Povidone-Iodine
- Where
- United States
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
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 Cancer, Breast Implant; Complications, Infection or Inflammation
Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction
Surgical mesh products, particularly acellular dermal matrices (ADM), are now used by the majority of plastic surgeons to assist with the nearly 100,000 prosthetic breast reconstruction procedures in the United States, despite…
- Trial name
- NCT05190978
- Testing
- Acellular Dermal Matrix, Reconstruction without ADM
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- University of California, Los Angeles
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
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
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
Infections, Quality of Life
Effect of Drain Care on Infection Rate and Quality of Life in Implant-Based Breast Reconstruction.
The goal of this clinical trial is to learn whether showering with surgical drain tubes in place after first stage breast reconstruction causes increased risk of infection.
- Trial name
- NCT05846438
- Testing
- Showering 48 hours after surgery
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Missouri-Columbia
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
Breast Implant Infection, Mammoplasty
Bacterial Biofilms in Reconstructive Breast Prostheses Following Mastectomy
Breast implants, either cosmetic or reconstructive, are among the most common procedures performed by plastic surgeons. Bacterial infections or biofilms are implicated in the majority of breast implant complications including…
- Trial name
- NCT03213249
- Testing
- Normal saline, Cefazolin, Skin biopsy
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Washington University School of Medicine
Breast Cancer
A Study of Antibiotic Delivery to Prevent Infection After Breast Tissue Expander Placement
The researchers are doing this study to find out whether Stimulan Rapid Cure works to reduce the risk of infections in people getting tissue expanders placed during mastectomy.
- Trial name
- NCT07220967
- Testing
- Tissue Expander (TE), Vancomycin and Gentamicin, Stimulan Rapid Cure
- Where
- 7 sites in United States
- Volunteers
- 392 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast Cancer, Breast Cancer Female
Microbiome and Association With Implant Infections
The most common tissue expander-related infections are from Staphylococcus and Pseudomonas species. In addition, from breast tissue microbiome studies, Staphylococcus and Pseudomonas show variable abundance across samples.
- Conditions
- Breast Cancer, Breast Cancer Female, Genetic Predisposition to Disease
- Trial name
- NCT05020574
- Testing
- Cephalexin
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- University of California, San Francisco