Trials / Recruiting
RecruitingNCT06501105
Performance of WOUNDCHEK Bacterial Status
Clinical Study to Evaluate the Performance of WOUNDCHEK Bacterial Status
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 75 (estimated)
- Sponsor
- Woundchek Laboratories BV · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this clinical study is to evaluate the performance of WOUNDCHEK™ Bacterial Status (WCBS) when the test result is used to inform treatment decisions.
Detailed description
The clinician treating the wound will be allowed to use the test result in treatment decisions. The pretest treatment plan will be documented on the Case Report Form (CRF) prior to performing the WCBS test. After receiving the test result the clinician will document the post-test treatment plan. The healing outcome at 12 weeks following the test will be recorded on the CRF. The study will evaluate the healing outcomes compared to when test results are not used to assist in treatment decisions with study success defined as a higher healing rate and/or mean wound size reduction for WCBS positive wounds than obtained in the study PROT-2023-001. Also, the healing rate of wounds with a negative test result will be compared to the pretest rate to ensure that clinicians do not neglect and under treat this cohort with success criteria being that the WCBS negative wound healing rate is not worse than the pre-test healing rate. Additionally, the study will establish whether there are any device related Serious Adverse Events (SAEs) or Unanticipated Adverse Device Effects (UADEs).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | WOUNDCHEK Bacterial Status | Lateral flow point of care test for the qualitative detection of bacterial protease activity in wound fluid. |
Timeline
- Start date
- 2024-06-18
- Primary completion
- 2024-10-01
- Completion
- 2024-12-01
- First posted
- 2024-07-15
- Last updated
- 2024-07-15
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06501105. Inclusion in this directory is not an endorsement.