Clinical trials: Biofilms
Prosthetic Joint Infection
Abbreviated Protocol for Two-Stage Exchange
Study Type: A multi-site, parallel group, randomized trial. Study Objectives: The objective is to evaluate safety and determine preliminary efficacy of VT-X7 (Vancomycin and Tobramycin Exchanged over 7 Days).
- Trial name
- APEX (NCT04662632)
- Testing
- VT-X7 Treatment System with Tobramycin Sulfate, Standard of Care, Two-stage exchange arthroplasty
- Where
- 17 sites in United States
- Volunteers
- 76 people
- Sponsor
- Osteal Therapeutics, Inc.
Drug Related Side Effects and Adverse Reactions, Infusion Reactions
Retrospective Kinetic Safety Evaluation of an Intravenous Micellar Excipient Platform
Protocol PICO-RWE-001: The goal of this observational study is to evaluate the kinetic safety and tolerability of an investigational intravenous micellar delivery platform.
- Trial name
- NCT07609069
- Testing
- PIV-850 (850-picometer Dual-NCE Acidic Matrix), Legacy Heterogeneous Payload (Micellar Vehicle)
- Where
- United States
- Volunteers
- 625 people
- Sponsor
- PICO IV, Inc.
Dental Biofilm Accumulation
RCT: Enzyme Blend Toothpaste on Dental Biofilm Plaque Accumulation
The aim of the study is to investigate whether brushing twice a day with a toothpaste (Biofresh Clean) containing a blend of alpha-amylase and gluco-amylase improves oral health outcomes over a 14-day period.
- Trial name
- NCT07079683
- Testing
- Toothpaste Product
- Where
- United States
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- Novozymes A/S
Prosthetic-joint Infection
A Second Trial of the Abbreviated Protocol Two-Stage Exchange
Apex-2 is a multi-site, parallel group, randomized trial. Patients will be randomly assigned in a 1:1 ratio to the Experimental Arm or the Control Arm.
- Trial name
- Apex-2 (NCT05607030)
- Testing
- VT-X7 Treatment System, Two-stage exchange arthroplasty, SOC Antibiotics
- Where
- 19 sites in United States
- Volunteers
- 76 people
- Sponsor
- Osteal Therapeutics, Inc.
Chronic Leg Ulcer, Venous Leg Ulcer
Safety and Tolerability of Single and Multiple Doses of SoftOx Biofilm Eradicator (SBE) in Chronic Leg Wounds
Single-centre clinical study investigating the safety and tolerability of randomised, double-blinded, placebo-controlled ascending single doses of topically applied SoftOx Biofilm Eradicator (SBE) in patients with chronic leg…
- Trial name
- NCT05710094
- Testing
- SoftOx Biofilm Eradicator (Groups 1 to 7), Sterile isotonic saline (Groups 1 to 4)
- Where
- Denmark
- Volunteers
- 28 people
- Sponsor
- SoftOx Solutions AS
Mechanical Ventilation, Pneumonia
Removal of Endotracheal Tube Secretions Comprehensively Until Extubation
The purpose of this study is to measure secretion accumulation within endotracheal tubes of mechanically ventilated patients and test the efficacy, safety and clinical impact of removing the secretions using novel airway…
- Trial name
- RESCUE (NCT00663637)
- Testing
- CAM (Complete Airway Management) Catheters
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- O. M. Neotech, Inc.
Surgical Wound, Surgical Site Infection
Clinical Assessment of Next Science Wound Gels in Healing Below the Knee Amputation Surgical Wound Compared to SOC
This is a 64-patient, 90-day, open -label study on adult patients undergoing below knee amputation for various etiologies. The objective of this study is to assess surgical wound healing and wound bioburden using combination…
- Conditions
- Surgical Wound, Surgical Site Infection, Surgical Wound Infection, Amputation Stump; Infection
- Trial name
- NCT04053946
- Testing
- Next Science Wounds Gels
- Sponsor
- Next Science TM
Healthy Adults, Plaque, Dental
Photodynamic Treatment in the Management of Residual Biofilm - a Crossover Study
This research introduces a home-use dual-light antibacterial medical device and its possible added value as part of traditional dental self-care.
- Trial name
- NCT06860321
- Testing
- Adjunct antibacterial home-use dual-light medical device, Regular oral self care
- Where
- Finland
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Koite Health Oy
Hemodialysis
Ex Vivo Microbiological Assessment of an Anti-biofilm Catheter in Acute Dialysis Application
The clinical study aims at providing data on antimicrobial efficiency and a supposed additional preventive effect on catheter-related infections of a catheter with antibacterial surface coating in comparison to standard catheters…
- Trial name
- ABBA (NCT00621114)
- Testing
- GamCath® central venous catheter, GamCath Dolphin® Protect central venous catheter
- Where
- Germany
- Volunteers
- 69 people
- Sponsor
- Vantive Health LLC
Rhinosinusitis Chronic, Microbiome
Impact of Symbiofilm On Nasal Microbiota
Healsea® chronic is CE marked medical device indicated in adults for the treatment of nasal symptoms of chronic rhinosinusitis. This is an hypertonic seawater-based nasal spray supplemented with natural Symbiofilm® extract (0.2%)…
- Trial name
- ISONAM (NCT05015530)
- Testing
- Healsea® Chronic, hypertonic seawater-based nasal spray supplemented with natural Symbiofilm® extract
- Where
- France
- Volunteers
- 12 people
- Sponsor
- Lallemand Pharma AG
Wound Infection
Biofilm Correlation and Validation
This is a prospective, single-blind, controlled trial. There are two arms and 20 patients with acute or chronic wounds with clinical suspicion of biofilm (CSB+/CSB-) are allocated in each arm.
- Trial name
- NCT05196880
- Testing
- MolecuLight DX Imaging Device
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- MolecuLight Inc.
Acute Wound
Cleanser for Acute Wounds
The proposed study will be a prospective trial of management of acute traumatic wounds (less than 24 hours from injury and without previous intervention aside from a dressing for coverage).
- Trial name
- NCT05422144
- Testing
- Antimicrobial Skin & Wound Cleanser (AWC), Antimicrobial Wound Gel (AWG)
- Where
- United States
- Sponsor
- Rochal Industries LLC
Partial Thickness Wound, Pressure Ulcer
The RESPOND Registry
The RESPOND Registry is an observational study to assess the impact of PuraPly™ AM on the management of wounds in real world clinical settings; no experimental intervention is involved.
- Conditions
- Partial Thickness Wound, Pressure Ulcer, Venous Ulcer, Diabetic Ulcer
- Trial name
- RESPOND (NCT03286452)
- Testing
- PuraPly™ Antimicrobial Wound Matrix
- Where
- 15 sites in United States
- Volunteers
- 310 people
- Sponsor
- Organogenesis
Biofilm Formation, UTI
Randomized Study of Silq Urinary Catheter
To assess the ability of the Silq ClearTract™ 100% Silicone 2-Way Foley Catheter to reduce biofilm formation in subjects that require a long-term indwelling Foley catheter when compared to other commercially available urinary…
- Trial name
- NCT04841226
- Testing
- Long-term indwelling Foley catheter
- Where
- 8 sites in United States
- Volunteers
- 158 people
- Sponsor
- Silq Technologies Corporation
Dental Plaque
Effect of Enzymes on Dental Biofilm Accumulation
Double-blind, placebo-controlled, cross-over study investigating dental biofilm accumulation after 4-days in 28 subjects randomised to receive: Sequence 1: 5 active enzyme-containing lozenges per day for 4-days followed by a…
- Trial name
- NCT05579938
- Testing
- Enzyme-containing lozenge
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Novozymes A/S
Prosthetic Joint Infection
Safety and Efficacy in Patients Treated for Hip or Knee PJI With Vancomycin and Tobramycin Joint Irrigation
Study Type Prospective, single-arm, open-label, multicenter (3 to 5 sites), interventional trial. Primary Study Objective The objective of the study is to determine the safety profile of local antibiotic irrigation for the…
- Trial name
- NCT03721328
- Testing
- vancomycin hydrochloride and tobramycin sulfate
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- Osteal Therapeutics, Inc.
Dental Plaque, Gingivitis
Effect of an Enzyme-containing Lozenge on Dental Biofilm in Healthy Individuals.
The purpose of the study is to assess the effect of an enzyme containing lozenge on dental plaque accumulation in healthy adults.
- Conditions
- Dental Plaque, Gingivitis, Microbial Colonization
- Trial name
- NCT05070507
- Testing
- Enzyme containing lozenge
- Where
- Denmark
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Novozymes A/S
Dental Biofilm Accumulation
Effect of Enzyme-containing Lozenge on Dental Biofilm Formation, Composition and Functionality
A double-blind, placebo-controlled randomized cross-over trial evaluating the effect of enzyme-containing lozenge on in vivo and in situ grown dental biofilm accumulation.
- Trial name
- NCT06142409
- Testing
- Enzyme containing lozenge
- Where
- Denmark
- Volunteers
- 34 people
- Sponsor
- Novozymes A/S
Prosthetic Joint Infection of Knee
Sola2 AMF Knee System Added to Surgery and Antibiotics in Adults With Knee Implant Infection
The goal of this clinical trial is to learn whether the Sola2 AMF Knee System, when added to surgery and antibiotic treatment, can safely improve outcomes, knee function, and quality of life in adults with knee implant infection.
- Trial name
- AMPLIFY (NCT07700927)
- Testing
- Intervention 1: Alternating Magnetic Field Treatment, Debridement, Antibiotics, Implant Retention
- Volunteers
- 165 people
- Sponsor
- Solenic Medical, Inc.
Lung Diseases, Pulmonary Disease
A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis
Although Cystic Fibrosis is a complex genetic disease affecting many organs, lung disease is the primary cause of mortality. The objective of this study is to determine the safety and tolerability of SNSP113 in healthy subjects…
- Conditions
- Lung Diseases, Pulmonary Disease, Cystic Fibrosis, Cystic Fibrosis Lung
- Trial name
- NCT03309358
- Testing
- Inhaled SNSP113
- Where
- 2 sites in United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Synspira, Inc.