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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06679023
Acronym
WBDK-GB
Enrollment
60
Registered
2024-11-07
Start date
2023-10-17
Completion date
2025-12-31
Last updated
2024-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biofilm Infection, Chronic Wound, Wound Healing

Keywords

chronic wound, wound healing, Biofilm detection

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.

Interventions

DIAGNOSTIC_TESTMolecuLight 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.

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
90-day wound healing90 daysobservation 90-day wound healing and its relationship with clinical data and biofilm severity.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026