Ignite Creation Date:
2024-05-06 @ 3:22 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04614870
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2020-10-28
Brief Title:
DETEC Esterase for Screening Wound Infection at Point of Care
Sponsor:
Progenitec Inc
Organization:
Progenitec Inc
Study Overview
Official Title:
Non-interventional Prospective Single-blinded Observational Multicenter Cohort Clinical Study to Evaluate DETEC Esterase for the Detection of Infections in Chronic Wounds
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This non-interventional single-blinded prospective observational study assesses the planar distribution of leukocyte esterase in wounds by placing wound exudates soaked wound dressings in the DETEC Esterase device during routine wound care The output of the device is correlated with clinical determination of infection to assess the device efficacy in identifying presumptive infections
Detailed Description:
There is no commercial available device to diagnosze infection in chronic wounds Since qualitative measures of leukocyte esterase LE 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 LE can also be used a a biomarker to screen infection in chronic wounds To test this hypothesis an investigational device - DETEC Esterase - has been developed to detect elevated LE in wound exudates absorbed wound dressings With increasing LE levels this coloration becomes more intense from colorlesspink to dark purple indicating infection
The overall goals of the study are as follows
1 To assess the efficacy of DETEC Esterase in detecting ulcer wound infection by comparing device output with the wound care specialists final determination of infection
2 To evaluate the effect of the subjects age race wound size location type and clinical site on the devices ability to identify non-healing wounds
3 To study the sensitivity specificity and accuracy of DETEC Esterase in assessing infection by testing discarded wound dressings with varying levels of esterase activities
Patients presenting themselves to the clinic with ulcer wounds will be assessed by the clinicians Those with at least one clinical sign and symptom of a wound infection will be enrolled and recorded in the study The participants first visit can be concurrent with enrollment During this visit the participants wound dressings will be tested using DETEC Esterase device by a project nursetester 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 may adjudicate the presence or absence of infection based on all available information to make a clinical diagnosis of infection The device determination of presumptive infection will then be compared with the results of the doctors adjudication
The overall goals of the study are as follows
1 To assess the efficacy of DETEC Esterase in detecting ulcer wound infection by comparing device output with the wound care specialists final determination of infection
2 To evaluate the effect of the subjects age race wound size location type and clinical site on the devices ability to identify non-healing wounds
3 To study the sensitivity specificity and accuracy of DETEC Esterase in assessing infection by testing discarded wound dressings with varying levels of esterase activities
Patients presenting themselves to the clinic with ulcer wounds will be assessed by the clinicians Those with at least one clinical sign and symptom of a wound infection will be enrolled and recorded in the study The participants first visit can be concurrent with enrollment During this visit the participants wound dressings will be tested using DETEC Esterase device by a project nursetester 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 may adjudicate the presence or absence of infection based on all available information to make a clinical diagnosis of infection The device determination of presumptive infection will then be compared with the results of the doctors adjudication
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None