Wound Biofilm Detection Kit Development: Validation of Grading System With Biofilm Severity (WBDK-GB)

National Taiwan University

Status: Active, not recruiting

Conditions: Chronic Wound; Wound Healing; Biofilm Infection

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

Study type: Observational

Funder types: Other

Identifiers

NCT06679023

202304083DINB

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.