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

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.

NCT Number	NCT06679023
Lead Sponsor	National Taiwan University Hospital
Conditions	Chronic Wound, Wound Healing, Biofilm Infection
Enrollment	60 participants
Start Date	2023-10-17
Primary Completion	2024-07-15 (estimated)
Study Completion	2025-12-31 (estimated)
Updated on ClinicalTrials.gov	2024-11-07