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Prosthesis-related Infections clinical trials

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NCT ID: NCT04520841 Recruiting - Amputation Clinical Trials

Clinical Trial Comparing Negative Pressure Wound Therapy and Standard Dry Dressings

BERLYTZ
Start date: June 1, 2020
Phase: N/A
Study type: Interventional

Negative pressure dressings are currently widely used in wound management. Their use is gradually being extended to surgical scars. However, studies demonstrating a clear benefit are rare, particularly in terms of postoperative discharge, the need for surgical revision due to prolonged oozing and cost. The aim of this study is to evaluate the benefit of such a device in post-operative revision prosthesis surgery (hip and knee), as well as lower limb amputations.

NCT ID: NCT04440631 Completed - Fractures, Bone Clinical Trials

Gut Microbiome of Patients Undergoing Antibiotic Therapy for Orthopedic Device-related Infection

IMPAT-ODRI
Start date: November 1, 2019
Phase:
Study type: Observational

The microbiome of 80 orthopedic-device related infection (ODRI) patients treated with antibiotics and 10 healthy controls will be investigated. Samples (blood, stool, saliva, skin-swab) are collected 4x within 6 months. Composition and diversity of the microbiome will be assessed by 16sRNA sequencing, skins swabs are screened for rifampicin-resistant staphylococci onto Mannitol-salt-agar plates supplemented with rifampicin, inflammation markers and antibodies in blood and saliva are monitored to track changes in the immune response. For further analysis patients are assigned to one of two groups: 1) antibiotic therapy including rifampicin and 2) non-rifampicin antibiotic therapy.

NCT ID: NCT04304885 Recruiting - Joint Infection Clinical Trials

Effect of Sonication on Periprosthetic Joint Infection Treatment Strategy.

Start date: March 15, 2020
Phase:
Study type: Observational [Patient Registry]

It is not known in the literature how much sonication affects the patient's treatment. Another important issue is that the place of this method in diagnosis is not clear. The aim of this study is to contribute to the literature on this issue and to determine the sensitivity and specificity of sonication prospectively using the new definition and effect of sonication on the treatment strategy in terms of infection in patients with PJI.

NCT ID: NCT04016870 Enrolling by invitation - Bradycardia Clinical Trials

Project My Heart Your Heart: Pacemaker Reuse

MHYH
Start date: October 13, 2018
Phase: N/A
Study type: Interventional

Lack of access to pacemakers is a major challenge to the provision of cardiovascular health care in Low and Middle Income Countries (LMIC). Post-mortem pacemaker utilization could be safe, efficacious, and ethically responsible means of delivering the needed care. Reconditioned pacemakers can provide therapy for patients with symptomatic bradycardia and no means of receiving a new device. The objective of the clinical trial is to determine if pacemaker reutilization can be shown to be a safe means of delivering pacemakers to patients in LMIC without resources. Consented patients in this multi-center trial will be randomized to undergo implantation of either a reconditioned device or a new device.

NCT ID: NCT03444571 Recruiting - Clinical trials for Prosthesis-Related Infections

PRO-DIAG: Improved Diagnosis of Prosthetic Joint Infections

PRO-DIAG
Start date: February 16, 2018
Phase: N/A
Study type: Interventional

Implantation of joint prostheses is currently the second largest diagnosis-related group in the Danish health service, and in view of the demographic development and spread of lifestyle diseases, this type of intervention is expected to continue to increase. Unfortunately, 5% of patients experience significant discomforts and complications. The second most frequent and serious complication is infection. While the established laboratory analyses (culture of tissue biopsies) are good at diagnosing acute infections, they are not satisfactory to diagnose a large group of patients especially with chronic infections. This can lead to prolonged diagnosing time and even to wrong diagnosis. Several studies have shown that analyses of prosthetic parts and the use of molecular biological methods for detecting infecting microorganisms can significantly improve diagnostics accuracy. The purpose of this project is primarily to demonstrate that analyses of bacterial specific DNA (16S rRNA genes) can confirm or rule out infection as fast (or faster) as cultivation methods. Rapid clarification can promote targeted treatment and in order to demonstrate this, the trial is conducted as a randomized study. .

NCT ID: NCT03274466 Completed - Clinical trials for Postoperative Complications

Closed Incision Negative Pressure Therapy Versus Standard of Care Surgical Dressing in Revision Total Knee Arthroplasty

PROMISES
Start date: December 5, 2017
Phase: N/A
Study type: Interventional

This study evaluates surgical site complications in subjects undergoing revision of a total knee arthroplasty when closed incision negative pressure therapy is used to manage the closed incision, as compared to a standard of care dressing.

NCT ID: NCT03263832 Active, not recruiting - Clinical trials for Staphylococcus Aureus

Evaluation of the Antibiofilmogramme Test During Orthopaedic Device-Related Infection

BJIBiofilm
Start date: June 1, 2015
Phase:
Study type: Observational [Patient Registry]

This is an observational study that does not change routine care. The primary objective of this study is to investigate the correlation between the administration of an antibiotherapy able to prevent biofilm formation according to the results of the Antibiofilmogramme test, and the relapse of the infection for patient with orthopaedic device-related infection.

NCT ID: NCT03121183 Active, not recruiting - Heart Failure Clinical Trials

Medico-economic Evaluation of Strategies for the Lead Extraction of Implantable Defibrillator and Pacemakers

GAINE LASER
Start date: March 2015
Phase: N/A
Study type: Observational

The growing use and the expanding indications for cardiovascular implantable electronic devices (CIEDs) have been associated to an increase of device removal. The indications of CIEDs removal are infectious (55%) or noninfectious (45%) such as upgrading of devices, nonfunctional devices and thrombosis. Removal can be performed according to transvenous or surgical procedures. Transvenous lead removal (TLR) must be done by experimented cardiologists and respecting current consensus. TLR can be done with conventional techniques involving inserting locking stylets and telescoping sheaths around the pacing leads to separate them from the surrounding scar tissue. These conventional procedures have a success rate of ≈65%. TLR thanks to laser sheath has been validated and improved the success rate until >95%. However, the TLR from chronically implanted CIEDs still carries a significant risk of procedural failure, morbidity, and mortality, related to tearing of the great vessels and cardiac structures, even when performed by experienced operators. Even if the transvenous extraction using laser sheath seems to be more effective, this strategy would be more expensive. Considering the availability of several strategies for TLR and the cost heterogeneity of procedures, a cost assessment in real life of these therapeutic strategies is essential for an optimal choice of therapeutic strategies.

NCT ID: NCT03067909 Completed - Clinical trials for Surgery--Complications

Antithrombotic Therapy in Patients Undergoing CIED Surgery - HEMATOMA NO MORE Registry

Start date: May 2016
Phase:
Study type: Observational [Patient Registry]

Hundreds of thousands patients undergo implantation or replacement of cardiac implantable electronic devices (CIEDs) annually in Europe, and up to 50% of these subjects receive antiplatelet agents or oral anticoagulants. Antithrombotic therapy increases the risk of developing pocket hematoma which in turn is associated with an increased risk of potentially fatal device-related infections when clinically significant. Aim of the registry is to retrospectively (pilot local registry in Tuscany) and prospectively (multicenter national registry in Italy) investigate the different strategies for the management of antithrombotic therapy and the related complication rates (1-month and 12-months) in patients undergoing CIED surgery in a real-world setting. The registry will also provide data on the economic impact of different management strategies and complications.

NCT ID: NCT02860767 Completed - Clinical trials for Prosthesis-Related Infections

Dosing of Antibiotics During Reimplantation of Infected Knee and Hip Prostheses

DOSOS
Start date: August 2016
Phase: N/A
Study type: Observational

The purpose of the study is to evaluate the concentrations of antibiotics used as empirical treatment in serum and periprosthetic tissues during reimplantation of infected hip and knee prostheses