DETEC® Esterase for Screening Wound Infection at Point of Care

Summary

Participation Requirements

Description

Qualitative measures of leukocyte esterase have been used clinically as a biomarker to screen for various infectious diseases including urinary tract infections, peritonitis and joint infections. It is likely that wound infection is also accompanied with the elevation of leukocyte esterase in wound ...

Qualitative measures of leukocyte esterase have been used clinically as a biomarker to screen for various infectious diseases including urinary tract infections, peritonitis and joint infections. It is likely that wound infection is also accompanied with the elevation of leukocyte esterase in wound fluid and on the wound dressing. To test this hypothesis, the proposed device - DETEC® Esterase - has been developed to detect elevated leukocyte esterase on wound exudates absorbed on the wound contacting surface of wound dressings. With increasing esterase levels, this coloration (from colorless/pink to dark purple) becomes more intense indicating infection. Patients presenting themselves to the clinic with ulcer wounds will be assessed by the clinicians. Those with or without clinical signs and symptoms of a wound infection will be enrolled and recorded in the study. The participant's first visit can be concurrent with enrollment. During this visit, the leukocyte esterase on wounds will be assessed by testing wound exudate adsorbed on to participants' wound dressings using the DETEC® Esterase device by a project nurse/tester not involved with subjects' wound management and the output recorded. Wounds will be managed by the clinicians who are blinded from the device output. Consequently, the clinician will send the wound fluids/tissue samples from patients for microbiological laboratory testing. Within 15 days following the first visit, the presence or absence of infection will then be adjudicated by the provider based on all information. The device output will then be correlated with this adjudication.

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