Performance of WOUNDCHEK Bacterial Status

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-18

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

WOUNDCHEK Bacterial Status Benefits Evaluation

NCT03678636

Chronic Wounds

COMPLETED NA

Collection of Samples for the Evaluation of Wound Biofilm in Acute and Chronic Wounds

NCT00764296

Wounds

COMPLETED

Evaluation of Wound Biofilm in Acute and Chronic Wounds

NCT00764348

Wounds

WITHDRAWN

A Preliminary, Non-comparative Study to Evaluate a Bioresorbable Wound Scaffold in Acute Wounds

NCT01081522

Pilonidal Sinus

COMPLETED

Obtaining and Storing Standard of Care Wound Biopsies for Immediate or Future Wound-Related Scientific Study

NCT00759889

Diabetic Foot Leg Ulcer Decubitus Ulcer

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Wound Heal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

WOUNDCHEK Bacterial Status positive

Wounds positive for bacterial protease activity that may delay healing if untreated. Pre- and post-test treatment plan recorded.

WOUNDCHEK Bacterial Status

Intervention Type DEVICE

Lateral flow point of care test for the qualitative detection of bacterial protease activity in wound fluid.

WOUNDCHEK Bacterial Status negative

Wounds negative for bacterial protease activity. Pre- and post-test treatment plan recorded.

WOUNDCHEK Bacterial Status

Intervention Type DEVICE

Lateral flow point of care test for the qualitative detection of bacterial protease activity in wound fluid.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

WOUNDCHEK Bacterial Status

Lateral flow point of care test for the qualitative detection of bacterial protease activity in wound fluid.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Subject has presented to the participating study site with a VLU, DFU and / or a PU that is suspected not to be infected, as determined by the Investigator and/ or study staff - defined as one that does not show more than two of the NERDS signs of infection.
2. Subject is 18 years of age or older.
3. The wound is between 21 days and 6 months of age or more than 6 months of age if less than 1cm2 in area.
4. Subject agrees to complete all aspects of the study and provides written Informed Consent per IRB requirements.

2. Target wound contains a malignancy.
3. Subject has hypersensitivity of the wound or painful wound surface which prevents touching/swabbing of the wound surface.
4. Subject is confirmed to be positive for HIV or hepatitis

.
5. Subject is unable or unwilling to provide informed consent.
6. A designated wound area may only be enrolled once in the study. For example, if an enrolled wound heals to complete closure and then re-opens, it cannot be re-enrolled in this study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No