Clinical trials: Biofilms
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
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
Chronic Sinusitis
Nitric Oxide Releasing Sinus Irrigation (NOSi) to Treat Recalcitrant Chronic Rhinosinusitis (RCRS)
This a single center, randomized controlled trial to evaluate safety \& efficacy of topical nitric oxide releasing sinus irrigation (NOSi) as compared to budesonide-Saline (Control) in the management of biofilm-associated…
- Trial name
- NCT04163978
- Testing
- Nitric Oxide, Budesonide
- Where
- Canada
- Volunteers
- 56 people
- Sponsor
- Sanotize Research and Development corp.
Dental Plaque
Effect of Enzymes on Dental Biofilm Accumulation in Healthy Individuals
The purpose of the study is to assess the effect of enzyme containing lozenges on dental plaque accumulation in healthy adults.
- Trial name
- NCT05082103
- Testing
- Enzyme lozenge 1, Enzyme lozenge 2
- Where
- Denmark
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Novozymes A/S
Patients With Uncomplicated Long-term Central Venous Catheter-related Biofilm-related Infection
Conservative Treatment of Catheter - Related Injections With Gentamicine/EDTA
Catheter-related infections are frequent. Treatment without catheter removal is difficult because of the presence of biofilm. The association of gentamicin and EDTA is active in vitro and in vivo against biofilms formed by Gram…
- Trial name
- CATH-GE (NCT04789928)
- Testing
- Gentamicins-EDTA
- Where
- 6 sites in France
- Volunteers
- 8 people
- Sponsor
- Institut Pasteur
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
Expanded Access to Cyclic Irrigation in Patients Undergoing Exchange Arthroplasty
The objective of the protocol is to provide access to the VT-X7 (Vancomycin, Tobramycin Exchanged in 7 Days) system for subjects with periprosthetic joint infection (PJI) of the hip or knee who lack therapeutic treatment…
- Trial name
- APEX-EAP (NCT06383611)
- Testing
- VT-X7 Treatment System
- Where
- 14 sites in United States
- Sponsor
- Osteal Therapeutics, Inc.
Prosthetic Joint Infection
Study to Evaluate Safety and Activity of TRL1068 in Prosthetic Joint Infections
TRL1068 is expected to eliminate the pathogen-protecting biofilm in the prosthetic joint and surrounding tissue, thus making these pathogens substantially more susceptible to established antibiotic treatment regimens.
- Trial name
- NCT04763759
- Testing
- TRL1068, a human monoclonal antibody
- Where
- 9 sites in United States
- Volunteers
- 15 people
- Sponsor
- Trellis Bioscience LLC
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.
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
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.
Urinary Tract Infections
Efficacy of BLASTX in Catheter Associated Bacteriuria Versus Standard of Care (SOC)
This is a 2-week, single-site, randomized study in adults requiring short-term (≤ 14 days) catheterization. Subjects will be randomized 1:1 to either the biofilm disrupting gel (BLASTX) or SOC (McKesson Jelly) lubricated…
- Trial name
- NCT03176394
- Testing
- BLASTX Gel, McKesson Jelly
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Next Science TM
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.
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
Chronic Ulcers: Non-healing Deep Cavity Wounds (e.g., Diabetic Foot Ulcers, Arterial Ulcers, Post-surgical Wound Healing Disorders)
INJECTHEAL - Investigation of Chronic Wound Exudate and Biofilm
This prospective observational study will collect routine clinical waste material from 72 adults with chronic, non-healing wounds, including wound exudate from negative pressure therapy containers or sponges and wound…
- Trial name
- INJECTHEAL (NCT07745764)
- Testing
- standard of care
- Where
- Germany
- Volunteers
- 72 people
- Sponsor
- Barbara Wolff-Winiski