Clinical trial NCT04794621: Electroceutical Dressing Technology (EDT) Against Wound Microbial Biofilm Infection
Official title: Electroceutical Dressing Technology Against Wound Microbial Biofilm Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Heal
Keywords: surgical wounds
infected wounds
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Naval Medical Research Center
First posted: 2021-03-12
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two groups in parallel for the duration of the study
Primary purpose: TREATMENT

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 infections caused by microorganisms in the developed world involve biofilms. There clearly is a need for cost effective, highly stable, easily obtained biofilm targeted strategies for treatment of chronic wound biofilm infections.

The information generated from this project has the potential of providing considerable benefits to wound care by determining the efficacy of EDT dressing in managing wound biofilm infection and efficacy in wound healing and closure. Such knowledge could help therapeutic strategies and could provide information for future clinical studies to further understanding -of EDT wound dressings.

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/surgery chronic wounds against biofilm infection. This trial will determine the efficacy of EDT dressing against wound biofilm infection. subjects will be randomized to one of the two groups: 1) standard of care (SoC) only and 2) SoC + EDT dressing treatment. In group 2, in addition to SoC, the patients will apply the EDThi dressing (PED-10) on the wound(s) for the first 3 weeks following enrollment followed by Procellera® for additional 3 weeks. The use of dressings will be discontinued anytime if complete wound closure is achieved.

Eligibility criteria: Inclusion Criteria:

1. Ages 18 years and older
2. subjects willing and able to provide informed consent
3. patients with infected chronic trauma or surgical wounds
4. wound(s) must be able to be covered by the EDT dressing
5. 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.
6. Subjects must be able to read and understand English.

Exclusion Criteria:

1. Individuals who are deemed unable to understand the procedures, risks and benefits of the study, ie. Informed consent will be excluded
2. Pregnant women
3. Prisoners
4. Wound tissue not available for analysis
5. Patient with known sensitivity or allergic reaction to zinc or silver
6. Current active diagnosis of Osteomyelitis at the target wound site, that is untreated, based on clinical diagnosis per EMR.

Primary outcomes:
measure: Response to the use of EDT treatment in prevention of wound biofilm infection
timeFrame: 6 weeks
Secondary outcomes:
measure: rate of wound closure 6 weeks post-treatment as compared to baseline
timeFrame: 6 weeks
measure: wound microbiome in SoC and SoC+ EDT treatment.
timeFrame: 3 weeks
measure: Percent of patients with response to EDT treatment on week 6 as compared to SoC only group
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Eskenazi Health
state: Indiana
city: Indianapolis
country: United States
facility: Richard L. Roudebush VA Medical Center
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Health Methodist Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Sashwati Roy, PhD
role: PRINCIPAL_INVESTIGATOR
References: