Clinical trials: Implant Capsular Contracture
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 Cancer, Capsular Contracture Associated With Breast Implant
Predictive Toxicity Test Linked to Radiotherapy After Mastectomy and Immediate Implant Reconstruction
This study evaluates the capacity of the NovaGray RILA Breast® test to predict the toxicity linked to radiotherapy and the impact of implant breast reconstruction.
- Trial name
- PRETORIA (NCT04342546)
- Testing
- NovaGray RILA Breast® test
- Where
- 9 sites in France
- Volunteers
- 250 people
- Sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
Capsular Contracture Associated With Implant
Prevention of Capsular Contracture in Postmastectomy Patients Undergoing Implant-based Reconstructions
The study plans to evaluate capsular contracture at 1-year follow-up in postmastectomy patients receiving immediate implant-based reconstruction and Capsulase® supplementation in the postoperative period.
- Trial name
- NCT06785610
- Testing
- Capsulase®
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- European Institute of Oncology
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
Capsular Contracture Associated With Breast Implant, Capsular Contracture Grade III
Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation
Prospective, randomized, controlled study to assess the safety and effectiveness of GalaFLEX LITE™ Scaffold in revision surgery for reduction of capsular contracture recurrence and/or malposition in implant-based breast…
- Conditions
- Capsular Contracture Associated With Breast Implant, Capsular Contracture Grade III, Capsular Contracture Grade IV
- Trial name
- STANCE (NCT05945329)
- Testing
- GalaFLEX LITE™ Scaffold, Standard surgery
- Where
- 37 sites in United States
- Volunteers
- 250 people
- Sponsor
- C. R. Bard
Capsular Contracture of Breast, Grade III
Aspen™ Ultrasound System and Aspen Rehabilitation Technique in the Treatment of Capsular Contracture
Purpose: The purpose of this investigation is to test the safety and effectiveness of the Aspen System™ and Aspen Rehabilitation Technique.
- Trial name
- NCT02840084
- Testing
- Aspen(TM) Ultrasound System
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Nina Naidu
Capsular Contracture of Breast Implant
Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Clinically Significant Capsular Contracture
This prospective breast implant surveillance cohort will evaluate whether implant age, pocket plane, incision route, surface texture, and volume predict clinically significant capsular contracture.
- Trial name
- NCT07810231
- Testing
- Breast Implant Exposure, Standardized Capsular Contracture Assessment
- Where
- Colombia
- Volunteers
- 3,000 people
- Sponsor
- Research Inc
Breast Cancer
Clinical Trial to Evaluate the Safety and Efficacy of Breast Implant
The aim of this study is to evaluate the safety and efficacy of Cohesive Silicone Gel-Filled Breast Implant (CoSBI) produced by HansBiomed co.,Ltd. in breast reconstruction or augmentation
- Trial name
- NCT01711710
- Testing
- Cohesive Gel Breast Implant
- Where
- 2 sites in South Korea
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Postoperative Seroma Rate, Drainage Tube Removal Time, and Capsular Contracture Rate, Seroma Following Procedure
Pseudomonas Aeruginosa Injection Combined With Polyvinylpyrrolidone-Iodine in Immediate Breast Reconstruction Surgery With Implants
Brief Summary This study hypothesizes that in immediate breast reconstruction following tumor resection, the application of inactivated Pseudomonas aeruginosa preparation (PAP) may reduce infection rates by decreasing…
- Trial name
- RCT of PAI + P (NCT07460297)
- Testing
- Pseudomonas aeruginosa, Povidone-Iodine
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Jianyi Li
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
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
Breast Cancer
Capsular Contracture After PMRT Using Prepectoral Versus Subpectoral Implant-based Breast Reconstruction: PREPER Trial
The purpose of this study is to prospectively compare and analyze the incidence of complications in patients undergoing postmastectomy radiation therapy after breast reconstruction with subpectoral and prepectoral placement of…
- Trial name
- NCT04391296
- Testing
- Arm I (Prepectoral), Arm II (Subpectoral)
- Volunteers
- 114 people
- Sponsor
- Gangnam Severance Hospital
Capsular Contractures
Prevention of Capsular Contracture Using Trental and Vitamin E
The main purpose of this research study is to determine if the use of Trental and Vitamin E will decrease the incidence and severity of contractures (shrinking and or hardening of tissue surrounding the implant) associated with…
- Trial name
- NCT01082003
- Testing
- Trental
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Legacy Health System
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
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