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ACTIVE NOT RECRUITING
NCT06679023

Wound Biofilm Detection Kit Development: Validation of Grading System With Biofilm Severity

Sponsor: National Taiwan University Hospital

View on ClinicalTrials.gov

Summary

Chronic wound is a leading health issue in current health care system. Biofilm is a notorious risk factor of unhealed wound. Although biofilm-direct wound care has been a prevalent strategy of wound care currently, diagnosis of biofilm still remained as an unmet clinical need. Several advanced diagnostic tools of biofilm had been published in recent years, however, the evidence was still insufficient. In this study, we will enroll patients with chronic wounds, collect the wound debris, quantify the biofilm and validate with the signals of advanced diagnostic tools for biofilm detection, hoping to transform the tools which could only tell us whether the biofilm is present or not, into the severity of biofilm infection. The two tested tools includes of MolecuLight i:X and wound blotting and Alcian blue biofilm detection kit.

Official title: Biofilms in Chronic Wounds Pathogenesis and Diagnosis: Quantification of Biofilm and Validation of Grading System in Modified Alcian Blue Biofilm Detection Kit (WBDK-GB)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2023-10-17

Completion Date

2025-12-31

Last Updated

2024-11-07

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

MolecuLight i:X and Wound blotting and Alcian blue biofilm detection kit

we will enroll patients with chronic wounds and quantify the biofilm severity by staining color of Wound blotting and Alcian blue biofilm detection kit, and by non-touched flourescent intensity of MolecuLight i:X.

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan