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

NCT06679023 | Active Not Recruiting

• 1 other identifier: 202304083DINB
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Wound; Wound Healing; Biofilm Infection

Keywords

chronic wound; wound healing; Biofilm detection

Outcome Measures

Primary Outcomes (1)

• 90-day wound healing

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

  90 days

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

chronic wound

You may qualify if:

• Age 18 or older
• Has an unhealed wound and is scheduled for debridement surgery
• Patients who are receiving wound care at this hospital (Hsinchu branch) and are able to comply with follow-up wound monitoring

You may not qualify if:

• Does not consent to provide remaining tissue from wound treatment for in vitro analysis.
• Allergic to nylon components.
• Under 18 years of age.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

chronic wound specimen

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 7, 2024
• Study Start: October 17, 2023
• Primary Completion: July 15, 2024
• Study Completion: December 31, 2025
• Last Updated: November 7, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)