Clinical Trials Logo
  1. Home
  2. Wound Infection
  3. NCT05196880
  4. Details
NCT05196880 Clinical Trial

Biofilm Correlation and Validation

Wound Infection Clinical Trial

Official title:
A Prospective, Single-blind, Clinical Evaluation of the MolecuLight DX in Combination With Biofilm Based Wound Care for the Identification of Biofilm Containing Wounds

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05196880
Other study ID # 21-002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 15, 2022
Est. completion date November 8, 2023

Study information
Verified date March 2024
Source MolecuLight Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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. The primary objective is to evaluate the diagnostic accuracy of MolecuLight fluorescence in identifying biofilm as validated by gold standard SEM imaging.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date November 8, 2023
Est. primary completion date May 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patients presenting with acute or chronic wounds 2. 18 years or older 3. Willing to consent Exclusion Criteria: 1. Treatment with an investigational drug within 1 month of enrolment 2. Any contra-indication to regular wound care 3. Inability or unwillingness to consent

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• MolecuLight DX Imaging Device
The MolecuLight DX Imaging Device is a fluorescence imaging device intended to acquire images from wounds. This will not alter the participant's standard of care treatment.

Locations
Country Name City State
Canada The Mayer Institute Hamilton Ontario

Sponsors (1)
Lead Sponsor Collaborator
MolecuLight Inc.

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic accuracy of fluorescence signature to predict presence or absence of wound biofilm measured by moderate/ heavy bacterial load 3 months
See also
  Status Clinical Trial Phase
Recruiting NCT02905955 - Vacuumtherapy After Venous Hybrid Procedures Phase 4
Not yet recruiting NCT02868372 - Swabbing of Subcutaneous Tissues of Cesarean Section Wounds With Povidone Iodine N/A
Enrolling by invitation NCT02559453 - Outcomes for 2 Operations Versus ≥ 3 Operations in Infected Wounds N/A
Completed NCT02744144 - Wound Bacterial Microbiota and Their Antibiotic Resistance N/A
Active, not recruiting NCT01939145 - Comparing Outcomes for Prontosan Versus Normal Saline for Negative Pressure Wound Therapy With Instillation Phase 4
Completed NCT01141335 - Polypropylene Mesh Versus Polytetrafluoroethylene (PTFE) Mesh in Inguinal Hernia Repair Phase 4
Completed NCT00998907 - PDS*Plus and Wound Infections After Laparotomy N/A
Terminated NCT00654641 - Prevention of Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy N/A
Completed NCT00576745 - A Comparison Of The 3M TM S Surgical Skin Closure System To The Standard Vicryl Suture Closure of Sternotomy Incisions During Cardiac Surgery Phase 1
Completed NCT00402727 - Comparison of Sequential IV/PO Moxifloxacin With IV Piperacillin/Tazobactam Followed by PO Amoxicillin/Clavulanic Acid in Patients With a Complicated Skin and Skin Structure Infection Phase 3
Recruiting NCT00150852 - Prevention of Gastrostomy-Related Wound Infection by Vancomycin in Carriers of Methicillin-Resistant Staphylococcus Aureus. Phase 2
Not yet recruiting NCT03872544 - Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Recruiting NCT04596124 - Effectiveness and Tolerability of Fitostimoline Plus Cream and Gauze vs Connettivina Bio Plus Cream and Gauze N/A
Active, not recruiting NCT04584957 - Prophylactic Negative Pressure Wound Therapy (VAC) in Gynecologic Oncology (G.O.) N/A
Recruiting NCT03960970 - Two-drug Antibiotic Prophylaxis in Scheduled Cesarean Deliveries Phase 2
Enrolling by invitation NCT03880188 - Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Completed NCT02018094 - The Amputation Surgical Site Infection Trial (ASSIT) Phase 4
Terminated NCT03269968 - Use of Negative Pressure Wound Therapy in Morbidly Obese Women After Cesarean Delivery N/A
Enrolling by invitation NCT02945761 - High Concentration of Sugar Solution Irrigation Promotes the Healing of Infected Wound N/A
Not yet recruiting NCT02882360 - Kerlix for Pregnant Women With Elevated BMI to Prevent Wound Infection by 6 Weeks Post Partum Phase 4