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

NCT06679023 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2024-11-07

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-17
Primary Completion
2024-07-15
Completion
2025-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06679023 on ClinicalTrials.gov