Wound Biofilm Detection Kit Development: Validation of Grading System With Biofilm Severity
- Conditions
- Chronic WoundWound HealingBiofilm Infection
- Registration Number
- NCT06679023
- Lead Sponsor
- National Taiwan University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- Does not consent to provide remaining tissue from wound treatment for in vitro analysis.
- Allergic to nylon components.
- Under 18 years of age.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 90-day wound healing 90 days observation 90-day wound healing and its relationship with clinical data and biofilm severity.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
National Taiwan University Hospital
🇨🇳Taipei City, Taiwan