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Biofilm clinical trials

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NCT ID: NCT05054244 Recruiting - Quality of Life Clinical Trials

Clinical Implications of Biofilm in Chronic Wound

Start date: July 1, 2021
Phase:
Study type: Observational

Chronic wounds are important economic and health-care problem. Biofilm has been recognized as a major factor in wound chronicity, delayed healing, and persistent infections, increasing the need for frequent dressing changes, painful debridement and systemic antimicrobial treatments influencing quality of life. In the presence of "un-cultivating" bacteria and limitations of clinical indicators of biofilm presence, there is a need for simple "screening" diagnostic method for biofilm detection. Chronic wounds of different etiology often associated with chronic pain reduce working abilities and cause restrictions in everyday living diminishing patient's quality of life. Efficacy of hyperbaric oxygenation therapy (HBOT) in treating chronic wound and associated infection has been suggested. This observational prospective cohort study will be conducted at the Department of undersea and hyperbaric medicine and Department of dermatovenereology, Clinical Hospital Center Rijeka during 3-year period from 2021. to 2024. including all patients treated due to chronic wound irrespective of the ethology. The patients will be evaluated upon enrolment, after 2, 4, 6 weeks, and 3, 6, 9, 12 months period, to clinically evaluate the wound characteristics, evaluate clinical healing rate, clinical indicators of biofilm and/or infection, need for additional diagnostic or treatment procedures. The patients in both groups (control and HBOT group) will be treated with standard treatment (dressings, debridement, antibiotics, infection control), in addition HBOT sessions will be performed (HBOT group). Impact of chronic wound and both treatment options to patient related outcome measures will be evaluated assessing intensity and pain characteristics, quality of life, depression, and anxiety by means of standardized questionnaires (visual analogue scale, McGill Pain questionnaire, Wound Quality of Life Index, Health Quality of Life Questionnaire, Beck depression and anxiety inventory). Microbiological analyses of swabs/biopsies will be evaluated to determine microbial profile and resistance. Detection and objectivization of biofilm will be evaluated by standard methods on microbiological isolates (Congo red agar, tube method, tissue culture plate method) and confocal scanning laser microscopy, and on clinical samples by light microscopy. Primary and secondary objective will be assessed after 1 year follow-up.

NCT ID: NCT04803695 Recruiting - Bronchiectasis Clinical Trials

Role of Pseudomonas Aeruginosa Biofilms in Exacerbations in Patients With Bronchiectasis With and Without Chronic Obstructive Pulmonary Disease

Start date: March 1, 2018
Phase:
Study type: Observational

Exacerbations, in particular during chronic Pseudomonas aeruginosa (PA) infection, are very important in the prognosis of patients with non-cystic fibrosis bronchiectasis (BE). In Cystic Fibrosis patients, PA biofilms are associated with chronic respiratory infections and are the primary cause of their increased morbidity and mortality. However, the presence and role in exacerbations of PA biofilms, microbiome dysbiosis and inflammatory biomarkers has not been studied in depth in BE patients. Our aim is to determine the association between PA chronic infection and its biofilms with the number of exacerbations in the next year (primary outcome), time until next exacerbation, quality of life, FEV1 and inflammatory biomarkers (secondary outcomes) in BE patients with or without chronic obstructive pulmonary disease (COPD). The investigators will include and follow up during 12 months post study inclusion, 48 patients with BE and 48 with BE-COPD, with a positive sputum culture of PA. During stability and follow up (and in each exacerbation) The investigators will collect 4 sputum, 4 serum samples, perform spirometry, and quality of life tests every three months. For the biomarkers subproject, 4 additional serum samples will be collected at: exacerbation, 3-5 days after treatment, at 30 days and three months post-exacerbation. Biomarkers will be measured by commercial kits and Luminex. The investigators will quantify PA colony forming units (CFU)/mL, their resistance pattern, their mutation frequency and isolate mucoid and non-mucoid colonies. In each sputum, the investigators will analyze by Confocal Laser Scanning Microscopy (CLSM) and Fluorescent in situ Hybridizatrion (FISH) PA biofilms, their size, bacterial density and their in situ growth rate. Specific serum antibodies against PA will be determined through Crossed Immunoelectrophoresis. In addition, the investigators will indentify potential respiratory microbiome and gene expression patterns predictive for exacerbations, or with a protective role against chronic PA infection, as well as their association with biofilms. Microbiome analysis will be performed through the Illumina Miseq platform. Finally, the investigators will explore the antimicrobial activity of novel combinations of antibiotics against PA, both in in vitro planktonic cultures and in a biofilm model, and will include testing of antibiotic-containing alginate nanoparticles.

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: NCT04247438 Completed - Biofilm Clinical Trials

Dentures Biofilm and Artificial Biofilm Substitute

KÜBI
Start date: March 2, 2020
Phase: N/A
Study type: Interventional

The biofilm on oral surfaces can lead to oral diseases. The correlation between oral biofilm and diseases and general health is well known. Therefore, cleaning of teeth or dentures from biofilm is essential for the maintenance of oral and general health. Currently, the society is ageing, the number of elderly as well as home and institutionalized care patients is increasing. In particular, these suffer from higher tooth loss, wear removable dentures and have problems with independent oral and denture hygiene. Therefore, support from well-trained nursing staff or family members is important. The use of suitable artificial biofilm substitutes may be helpful, in order to efficiently and easily perform oral and denture hygiene education, as well as to carry out laboratory tests of oral and denture hygiene products. The absence of such appropriate substitutes for denture biofilm requires innovations in this field. The aim of this pilot study is to verify the feasibility of the study protocol, design and methods. Additionally, an innovative artificial biofilm substitute based on polysaccharides will be further developed. This pilot study includes five study parts. Two in vivo examinations and three in vitro tests. This pilot study creates the basis for further main studies and implements the development of validated artificial biofilm substitutes.

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: NCT02853461 Recruiting - Clinical trials for Total Hip Replacement

Biofilm Investigation on Bearing Components of Explanted Hip Joint Prosthesis

Start date: June 2014
Phase: N/A
Study type: Observational

In this study the investigators sonicate the bearing components of the explanted hip prosthesis which allows highly sensitive detection of in vivo biofilms (qualitatively and quantitatively). The hip prosthesis bearing components are composed from different material. The purpose of this study is to analyse the resistance against biofilm adhesion of ceramic, metal and polyethylene prosthesis components through microbiologic analysis of sonicates.

NCT ID: NCT02845726 Completed - Morbidity Clinical Trials

Biofilms on Short-term Indwelling Ureteral Stents

Start date: July 2016
Phase: N/A
Study type: Observational

This study is performed to analyze various aspects of biofilms on ureteral stents.