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Active, Not Recruiting

NCT Number: NCT06679023

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Diagnostic Test

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.

Primary outcomes

  1. 90-day wound healing

    Time frame: 90 days

    observation 90-day wound healing and its relationship with clinical data and biofilm severity.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Biofilms in Chronic Wounds Pathogenesis and Diagnosis: Quantification of Biofilm and Validation of Grading System in Modified Alcian Blue Biofilm Detection Kit (WBDK-GB)

Acronym: WBDK-GB

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Nov 7, 2024
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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