Clinical trials: Implant Infection
Gingivitis
Clinical Study to Investigate a New Mouthwash in Reducing Plaque and Helping Prevent Gum Problems on Dental Implants Over a 6-month Period of Product Use
The objective of this six-month clinical research study is to evaluate the clinical efficacy of a new mouthwash on helping prevent gum problems (gingival index scores ) in adults as compared to a control mouthwash.
- Trial name
- NCT06770114
- Testing
- Cetylpyridinium Chloride, Zinc Lactate and Hyaluronic Acid Mouthwash, PhosFlur Mouthwash
- Where
- Italy
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Colgate Palmolive
Penile Implantation, Infections
Next Generation Sequencing Versus Traditional Cultures for Clinically Infected Penile Implants: Impact of Culture Identification on Outcomes
Randomized prospective study to evaluate next generation sequencing (NGS) and standard-of-care culture for clinically infected penile implants and to compare outcomes with identification of microbes.
- Trial name
- NCT05287438
- Testing
- Next-Generation DNA Sequencing, Standard Culture
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- MicroGenDX
Coronary Disease, Heart Valve Diseases
CTI-01 (Ethyl Pyruvate) Safety and Complication Prevention in Cardiac Surgery Patients on Cardiopulmonary Bypass (CPB)
Over 500,000 patients undergo cardiac surgery with CPB in the United States annually. Although mortality rates have decreased with advances in perioperative care, many patients are affected by postoperative organ dysfunction.
- Trial name
- NCT00107666
- Testing
- CTI-01 (ethyl pyruvate)
- Where
- 17 sites in United States
- Volunteers
- 150 people
- Sponsor
- Critical Therapeutics
Surgery
Prospective, Multicenter Observational Study Evaluating the Long Term Safety of the Custombone Implant
A Prospective, Multicenter Observational Study Evaluating the Long Term Safety in Terms of Explantation Rate and Number of Infections of the Custom-made Bioceramic Implant CustomBone™ The patients will be included as soon as they…
- Trial name
- CUSTOMBONE (NCT01824706)
- Testing
- craniectomy
- Where
- 18 sites in France
- Volunteers
- 110 people
- Sponsor
- Integra LifeSciences Corporation
Surgical Site Infection
Air Barrier System for the Prevention of Surgical Site Infection
Airborne particles are present in all indoor environments including the operating room. Most of these particles come from the surgical staff moving around in the room, positioning of the patient during surgery, and the movement…
- Trial name
- ABS (NCT01610271)
- Testing
- Air Barrier System
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Nimbic Systems, LLC
Prosthetic Joint Infection
Bacteriophage Therapy in Patients With Prosthetic Joint Infections (PJI)
This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections.
- Trial name
- ACTIVE2 (NCT05269134)
- Testing
- Bacteriophage
- Where
- 10 sites in United States
- Sponsor
- Adaptive Phage Therapeutics, Inc.
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
Peri-Prosthetic Joint Infection
IP-coated Revision Hip Implants
The primary aim of the clinical investigation is to demonstrate the efficacy of a silver-based antimicrobial coating on hip implants in the reduction of periprosthetic infections in revision hip arthroplasty due to periprosthetic…
- Trial name
- HIPrevision (NCT06737809)
- Testing
- IP Plasmafit® Revision cup (and stem) system
- Where
- 2 sites in Germany, Poland
- Volunteers
- 268 people
- Sponsor
- Aesculap AG
CIED Related Infection
World-wide Randomized Antibiotic Envelope Infection Prevention Trial
Medtronic , Inc. is sponsoring the World-wide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT), a randomized, prospective, multi-center, single blinded, post-market, interventional clinical study.
- Trial name
- WRAP-IT (NCT02277990)
- Testing
- TYRX™ Absorbable Antibacterial Envelope
- Where
- 181 sites in United States, Austria and 23 more
- Volunteers
- 7,075 people, healthy volunteers welcome
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Degenerative Disc Disease (DDD), Spinal Stenosis
PMCF Study on the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials
This is a prospective, multi-center, observational Post-Market Clinical Follow-Up (PMCF) study designed to collect additional safety and clinical performance data on CE-marked Titania® spinal instrumentation and fusion systems…
- Conditions
- Degenerative Disc Disease (DDD), Spinal Stenosis, Spondylolisthesis, Spinal Deformities
- Trial name
- INFO SPINE (NCT07615491)
- Testing
- Titania® Cervical Interbody Fusion Cage (Titanium), Titania® Cervical Interbody Fusion Cage (PEEK), Titania® Posterior Cervical Stabilization System
- Where
- 3 sites in Turkey (Türkiye)
- Volunteers
- 561 people
- Sponsor
- Metrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Co.
Noninfectious Posterior Uveitis
Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants
This is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide (FA) intravitreal implants for the management of subjects with non-infectious uveitis affecting the…
- Trial name
- NCT00407082
- Testing
- fluocinolone acetonide intravitreal implant, Fluocinolone acetonide 2.1mg
- Where
- United States
- Volunteers
- 278 people
- Sponsor
- Bausch & Lomb Incorporated
Sinusitis
Evaluation of the Middle Turbinate Implant for Affixing the Middle Turbinate to the Nasal Septum
The purpose of this study is to determine the functional performance of the Middle Turbinate Implant (MTI). The MTI will be used in all patients requiring endoscopic sinus surgery in which the Principal Investigator determines…
- Trial name
- MTI (NCT00896883)
- Testing
- Middle Turbinate Implant
- Where
- 4 sites in United States
- Volunteers
- 18 people
- Sponsor
- ENTrigue Surgical, Inc.
Degenerative Sacroiliitis, Sacroiliac Joint Disruption
Sacroiliac Joint Fusion With iFuse Implant System (SIFI)
The purpose of this study is to evaluate the use of the iFuse Implant System to treat degenerative sacroiliitis (arthritis of the SI joint) and sacroiliac disruption (abnormal separation or tearing of the sacroiliac joint).
- Trial name
- SIFI (NCT01640353)
- Where
- 26 sites in United States
- Volunteers
- 194 people
- Sponsor
- SI-BONE, Inc.
Central Venous Catheter Exit Site Infection, Catheter-Related Infections
Comparing CHG I.V. Securement Dressing With Transparent Dressing for Evaluation of Antimicrobial Efficacy
This is a single-center, prospective, randomized controlled clinical trial designed to compare the antimicrobial efficacy of Tegaderm CHG I.V.
- Trial name
- NCT04906512
- Testing
- 3M™ Tegaderm™ CHG I.V. Securement Dressing, 3M™ Tegaderm™ Transparent Film Dressing 1626W
- Where
- China
- Volunteers
- 123 people
- Sponsor
- Solventum US LLC
Cardiac Surgery, Sternal Wound Infection
Safety and Efficacy of an Antibiotic Implant in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Infection
The purpose of this study is to determine whether the gentamicin-collagen sponge is safe and effective in preventing sternal wound infections in patients undergoing cardiac surgery who are at a greater risk of developing sternal…
- Trial name
- NCT00600483
- Testing
- gentamicin-collagen sponge dipped in saline
- Where
- 43 sites in United States
- Volunteers
- 1,502 people
- Sponsor
- Innocoll
Uveitis, Posterior
Fluocinolone Acetonide Intravitreal Implant 0.18 mg in the Treatment of Chronic Non-Infectious Posterior Segment Uveitis
A study to evaluate the safety and efficacy of YUTIQ® 0.18 mg intravitreal implant for the management of chronic non-infectious posterior segment uveitis (intraocular inflammation) that has responded to previous steroid therapy.
- Trial name
- NCT05322070
- Testing
- Fluocinolone Acetonide Intravitreal Implant 0.18 mg
- Where
- 23 sites in United States
- Volunteers
- 125 people
- Sponsor
- Alimera Sciences
Staphylococcal Infections, Joint Prosthesis
StaphVAX Immunogenicity in Orthopedic Implant Patients
S. aureus is the most common pathogen involved in prosthetic joint infection. StaphVAX® is a vaccine to prevent these infections, which conjugates the purified capsular polysaccharides of S. aureus to a carrier protein.
- Trial name
- NCT00211926
- Testing
- S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Nabi Biopharmaceuticals
Non-infectious Uveitis
Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant vs Standardized Therapy
This is a 3 year,superiority, multicenter, open-label, randomised controlled safety and efficacy study. The aim of this study is to evaluate the effect of an intravitreal fluocinolone acetonide (0.59 mg) implant compared to…
- Trial name
- NCT00468871
- Testing
- fluocinolone acetonide intravitreal implant, corticosteroids and immunosuppressants
- Volunteers
- 140 people
- Sponsor
- Bausch & Lomb Incorporated
Cardiac Implantable Electronic Device Infection
TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD
The purpose of this study is to compare the incidence of cardiac implantable electronic device (CIED) infection and CIED mechanical complication after CIED replacement with a high-power cardiac implantable electronic device…
- Trial name
- Centurion (NCT01043705)
- Where
- 52 sites in United States
- Volunteers
- 1,262 people
- Sponsor
- TYRX, Inc.
Aspiration Pneumonia, Tracheostomy Complication
Intra-laryngeal Implant for Treatment of Chronic Aspirations
This study evaluates the medical device Newbreez LD is designed to protect the lower airways from saliva, liquids and food aspirations in tracheotomized patients suffering from chronic aspirations that require specific care and…
- Trial name
- NCT03325725
- Testing
- NewBreez LD intra-laryngeal implant
- Where
- 2 sites in France
- Sponsor
- ProTiP Medical