Clinical trials: Foreign Body Reaction
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
Lymphedema, Secondary, Lymphedema of Leg
Secondary Lymphedema Due to Human Adjuvant Disease
This observational, descriptive, retrospective study the clinical and imaging findings of 10 lower legs of 5 patients with previous history of injection of modeling substances for cosmetic purposes at buttocks and hips ande…
- Conditions
- Lymphedema, Secondary, Lymphedema of Leg, Granuloma, Foreign-Body
- Trial name
- NCT04588493
- Testing
- Lower extremity Lymphoscintigraphy
- Where
- Mexico
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Hospital Angeles del Pedregal
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-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
Foreign Body Granuloma, Surgery
"Outcomes of Surgical Removal of Foreign Body Granulomas"
Illicit subcutaneous injection of high-viscosity fluids for restoration and improvement of body contour is a growing trend all around the world. Many local and systemic complications have been described.
- Conditions
- Foreign Body Granuloma, Surgery, Complication
- Trial name
- NCT04661969
- Testing
- Surgery
- Where
- Mexico
- Volunteers
- 35 people
- Sponsor
- Hospital Angeles del Pedregal
Edematous, Synovitis
Double-Blinded Clinical Trial Using Apatone®B for Symptomatic Postoperative Total Joint Replacements
This research study is being conducted to determine if taking oral (by mouth in pill form) Apatone®B (a combination of Vitamins C and K3) will reduce chronic joint discomfort and improve function of non-infected symptomatic…
- Conditions
- Edematous, Synovitis, Foreign Body Reaction, Osteolysis
- Trial name
- Apatone-B (NCT01272830)
- Testing
- Apatone®B
- Where
- United States
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- IC-MedTech Corporation
Complications of Injectable Permanent Synthetic Fillers
Natural History of Injectable Permanent Synthetic Filler Disease
Injectable permanent synthetic filler disease is characterized by heterogeneous local and systemic manifestations that may emerge years after filler injection.
- Trial name
- NCT07867353
- Where
- Colombia
- Volunteers
- 450 people
- Sponsor
- Research Inc
Foreign-Body Reaction, Soft Tissue Filler Complication
Prospective Paired Evaluation of Conventional Versus Structured Magnetic Resonance Imaging Interpretation for Preoperative Assessment of Gluteal Permanent Synthetic Filler Disease
This prospective paired diagnostic-impact study will compare conventional qualitative MRI reporting with a new structured anatomic classification in adults undergoing surgery for gluteal permanent synthetic filler disease.
- Conditions
- Foreign-Body Reaction, Soft Tissue Filler Complication, Gluteal Permanent Synthetic Filler Disease
- Trial name
- NCT07808463
- Testing
- Conventional Qualitative MRI Interpretation, Structured Gluteal Filler MRI Classification, Standardized Intraoperative Anatomic Mapping
- Volunteers
- 200 people
- Sponsor
- Research Inc
Implant Capsular Contracture
Chemically Assisted Capsulectomy-A New Clinical Approach
The purpose of this study is to make available an agent,Mesna, which can assist the surgeon during the procedure of capsulectomy.
- Trial name
- NCT00758667
- Testing
- Mesna
- Volunteers
- 20 people
- Sponsor
- Vanderbilt University
Capsular Contracture Associated With Implant, Foreign-Body Reaction
Experimental and Clinical Investigation of the Implant Surface Roughness Reduction Effect on Early-stage Fibrosis
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…
- Conditions
- Capsular Contracture Associated With Implant, Foreign-Body Reaction, Wounds and Injuries, Tissue Expander Disorder
- Trial name
- NCT05648929
- Testing
- Patient Satisfaction Questionnaire, Pregnancy test, Blood draw
- Where
- Austria
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Medical University Innsbruck
Thermal Injury Response, Soft Tissue Disease
Ex Vivo Thermal Damage Assessment During Electrocautery Cutting of Explanted Biopolymer-Infiltrated Tissue
This prospective ex vivo study will evaluate thermal damage produced during electrocautery cutting of explanted tissue from patients undergoing clinically indicated surgical removal of gluteal biopolymers.
- Conditions
- Thermal Injury Response, Soft Tissue Disease, Granuloma, Foreign-Body, Foreign-Body Reaction
- Trial name
- THERM-BIOPOL (NCT07765576)
- Where
- Colombia
- Volunteers
- 50 people
- Sponsor
- Research Inc
Alveolar Ridge Preservation
Alveolar Ridge Preservation Procedures
Tooth loss is accompanied by different patterns of bone loss. Up to 50% loss of alveolar crestal bone width will likely occur 1 year after tooth loss, especially in the anterior maxilla.
- Trial name
- NCT05419778
- Testing
- Osteogen plug®, MInerOss®
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- University of Tennessee
Quality of Life, Granuloma, Foreign-Body
Postoperative Quality of Life in Treated Patients With Human Adjuvant Disease
This study aims to describe the quality of life in patients submitted to surgical excision of the adjuvants and injured surrounding tissue.
- Trial name
- NCT04579744
- Testing
- EuroQol 5D questionnaire
- Where
- Mexico
- Volunteers
- 11 people
- Sponsor
- Hospital Angeles del Pedregal
Foreign-Body Reaction, Inflammation
IMPACT: Safety and Feasibility of a Single-stage Procedure for Focal Cartilage Lesions of the Knee.
Articular cartilage defects in the knee have a poor intrinsic healing capacity and may lead to functional disability and osteoarthritis.
- Conditions
- Foreign-Body Reaction, Inflammation, Effusion (L) Knee, Knee Pain Swelling
- Trial name
- IMPACT (NCT02037204)
- Testing
- Cartilage repair surgery
- Where
- Netherlands
- Volunteers
- 35 people
- Sponsor
- UMC Utrecht
Gluteal Tissue Ischemia Risk, Foreign-Body Reaction
Prospective Agreement Study of Magnetic Resonance Imaging Measurements and Intraoperative Dimensions During Gluteal Permanent Synthetic Filler Removal
This prospective agreement study will compare preoperative MRI measurements with direct surgical measurements in adults undergoing removal of gluteal tissue affected by permanent synthetic fillers.
- Conditions
- Gluteal Tissue Ischemia Risk, Foreign-Body Reaction, Soft Tissue Filler Complication
- Trial name
- NCT07808996
- Testing
- Preoperative MRI Morphometric Mapping, Standardized Intraoperative and Fresh-Specimen Measurement
- Volunteers
- 220 people
- Sponsor
- Research Inc
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
Foreign-Body Reaction, Granulomatous Disease
Prospective Stage-Stratified Histopathologic Study and Proposed Disease-Evolution Model of Gluteal Permanent Synthetic Filler Complications
This prospective biospecimen cohort will collect and analyze tissue from adults undergoing clinically indicated surgery for gluteal permanent synthetic filler disease.
- Conditions
- Foreign-Body Reaction, Granulomatous Disease, Soft Tissue Necrosis Lower Limb, Gluteal Permanent Synthetic Filler Disease
- Trial name
- NCT07808970
- Testing
- Standardized Tissue Sampling During Clinically Indicated Surgery, Blinded Histopathologic Scoring
- Where
- Colombia
- Volunteers
- 200 people
- Sponsor
- Research Inc
Paraffinoma, Granuloma, Foreign-Body
The GranStone Trial
This study will investigate whether treatment with empagliflozin or losartan can reduce the risk of kidney stone formation in patients with paraffin disease, a condition caused by the injection of paraffin oil into muscle tissue…
- Trial name
- NCT07828002
- Testing
- empagliflozin (Jardiance) 25 mg, Losartan 100 mg
- Where
- Denmark
- Volunteers
- 100 people
- Sponsor
- Martin Blomberg Jensen
Capsular Contracture, Implant, Pediatric Cataract
Capsular Outcomes of Pediatric Cataract Surgery With Primary Intraocular Lens Implantation
Lens capsular often changes after pediatric cataract surgery，causing complications such as anterior capsulerhexis shrinkage, visual axis opacification (VAO), zonular dehiscence and so on.
- Trial name
- capsular (NCT04803097)
- Where
- China
- Volunteers
- 62 people
- Sponsor
- Yune Zhao