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Clinical Trials/NCT06679023
NCT06679023
Active, not recruiting
Not Applicable

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

National Taiwan University Hospital1 site in 1 country60 target enrollmentOctober 17, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Wound
Sponsor
National Taiwan University Hospital
Enrollment
60
Locations
1
Primary Endpoint
90-day wound healing
Status
Active, not recruiting
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
October 17, 2023
End Date
December 31, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 1.Age 18 or older
  • 2.Has an unhealed wound and is scheduled for debridement surgery
  • 3.Patients who are receiving wound care at this hospital (Hsinchu branch) and are able to comply with follow-up wound monitoring

Exclusion Criteria

  • Does not consent to provide remaining tissue from wound treatment for in vitro analysis.
  • Allergic to nylon components.
  • Under 18 years of age.

Outcomes

Primary Outcomes

90-day wound healing

Time Frame: 90 days

observation 90-day wound healing and its relationship with clinical data and biofilm severity.

Study Sites (1)

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