Status:
COMPLETED
Electroceutical Dressing Technology (EDT) Against Wound Microbial Biofilm Infection
Lead Sponsor:
Indiana University
Collaborating Sponsors:
United States Department of Defense
Naval Medical Research Center
Conditions:
Wound Heal
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
There are currently limited treatments available that show anti-biofilm efficacy for wound infection management Biofilms account for over 80% of infections and approximately 65% of nosocomial infectio...
Detailed Description
This is a randomized open-label clinical study to test the efficacy of the treatment protocol using an optimized EDThi \& EDTlo sequential approach in infected or high risk of infection burn/trauma/su...
Eligibility Criteria
Inclusion
- Ages 18 years and older
- subjects willing and able to provide informed consent
- patients with infected chronic trauma or surgical wounds
- wound(s) must be able to be covered by the EDT dressing
- All patients, with wounds below the knee, must have wound tissue oxygenation adequate to support wound healing per provider discretion, this may be defined by one or more of the following perfusion values within 6 months on enrollment: peri-wound transcutaneous oxygen measurements ≥ 25 mmHg (TCOM),Ankle Brachial Index (ABI) \>0.7, or a Toe pressure (TP) \> 40 mmHg, If none of these tests were performed during standard of care, then a trained study team member may obtain a TCOM measurement after the patient has consented and before they are enrolled. If there are multiple perfusion values that conflict, then a physician will review and determine if they are eligible for enrollment. If a patient has had a recent re-vascularization, the patient may be enrolled once adequate perfusion has been verified.
- Subjects must be able to read and understand English.
Exclusion
- Individuals who are deemed unable to understand the procedures, risks and benefits of the study, ie. Informed consent will be excluded
- Pregnant women
- Prisoners
- Wound tissue not available for analysis
- Patient with known sensitivity or allergic reaction to zinc or silver
- Current active diagnosis of Osteomyelitis at the target wound site, that is untreated, based on clinical diagnosis per EMR.
Key Trial Info
Start Date :
June 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2023
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT04794621
Start Date
June 3 2021
End Date
July 7 2023
Last Update
October 3 2023
Active Locations (3)
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1
Eskenazi Health
Indianapolis, Indiana, United States, 46202
2
Richard L. Roudebush VA Medical Center
Indianapolis, Indiana, United States, 46202
3
Indiana University Health Methodist Hospital
Indianapolis, Indiana, United States, 46228