NCT06679023

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
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Wound
• Wound Healing
• Biofilm Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-17
• Primary completion: 2024-07-15
• Completion: 2025-12-31
• First posted: 2024-11-07
• Last updated: 2024-11-07

Locations

1 site across 1 country: Taiwan