RECRUITING

Performance of WOUNDCHEK Bacterial Status

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Clinical Study to Evaluate the Performance of WOUNDCHEK Bacterial Status

Quick Facts

Study Start:2024-06-18

Study Completion:2024-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06501105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	1. Subject does not meet inclusion criteria. 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.

Inclusion Criteria

Exclusion 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.

1. Subject does not meet inclusion criteria.
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.

Contacts and Locations

Study Contact

Jack Wilkens, MBA

CONTACT

305 926 8380

jack.wilkens@woundchek.com

Simon W Bayliff, BS

CONTACT

+44 7917 650027

simon.bayliff@woundchek.com

Study Locations (Sites)

Northwell Health Comprehensive Wound Healing & Hyperbaric Center

Lake Success, New York, 11042

United States

Collaborators and Investigators

Sponsor: Woundchek Laboratories BV

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-18

Study Completion Date2024-12

Study Record Updates

Study Start Date2024-06-18

Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

Wound Heal