Wound Care
Conditions
Brief summary
The purpose of this research is to test if the investigational ParaNano WoundCue Kit can detect elevated inhibitory bacterial and/or fungal loads.
Interventions
DIAGNOSTIC_TESTHCy-hex™: a hemicyanine-based (HCy) lipase-responsive dye
HCy-hex™: a hemicyanine-based (HCy) lipase-responsive dye with a labile ester linkage, enzymatically cleavable by bacterial lipase released from clinically relevant strains of bacteria
Sponsors
ParaNano, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Arm 1: Subjects will be considered qualified for enrollment if they meet the following criteria: Subjects and/or Legally Authorized Representative (LAR) must voluntarily provide written Informed Consent, consisting of reading, signing, and dating the Informed Consent document after the Principal Investigator, sub-Principal Investigator, or other designated Study Staff member has explained the Study procedures, risks, and contact information. Able and willing to comply with all Study requirements. Subject can be Male or Female but must be over 21 years of age. Subject is currently under the care of a Primary Care Physician. Subject has an anticipated survival of greater than two months. Subject has a moderate to high exudate wound that has visible fluorescence when using MolecuLightDX™ or MolecuLight i:X™ imaging. Arm 2: Subjects will be considered qualified for enrollment if they meet the following criteria: Subjects and/or Legally Authorized Representative (LAR) must voluntarily provide written Informed Consent, consisting of reading, signing, and dating the Informed Consent document after the Principal Investigator, sub-Investigator, or other designated Study Staff member has explained the Study procedures, risks, and contact information. Able and willing to comply with all Study requirements. Subject can be Male or Female but must be over 21 years of age. Subject is currently under the care of a Primary Care Physician. Subject has an anticipated survival of greater than two months. Subject has a moderate to high exudate wound. \*For this Study, moderate exudate is defined as a wound that may require a dressing change 2-3 times a week based on provider judgement. Heavy exudate is defined as a wound that may require a dressing change 4 or more times a week based on provider judgement.
Exclusion criteria
* Subject's target treatment area has a surface area larger than 5 cm2. Known sensitivity or allergy to the Study Device or adhesives/adhesive-related products. Current use of topical ointments, including over-the-counter products and prescription drugs, on or near the intended treatment area. Current use or recent history (within the past 14 days) of antibiotics, either oral, systemic, or topical. Undergoing therapy with another investigational agent that may affect the WoundCueTM Kit's performance within thirty (30) days of Study Visit 1 or planned participation overlapping with this Study. Women who are pregnant, breastfeeding, or intend to become pregnant during the course of the Study. Medical condition that, in the opinion of the Principal Investigator, would preclude safe Subject participation in the Study. Adults who, in the judgment of the Investigator, lack the capacity to provide informed consent for themselves
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint: | 48 hours after screening | 80% correlation (1:1) in detection of elevated inhibitory bacterial and/or fungal load by WoundCue™ Kit and confirmed by laboratory testing. |
Contacts
CONTACTChelsea Luxen
Outcome results
None listed