Electroceutical Dressing Technology (EDT) Against Wound Microbial Biofilm Infection

Wound Heal Clinical Trial

— EDT BioFilm  

Official title:

Electroceutical Dressing Technology Against Wound Microbial Biofilm Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04794621
• Other study ID #: 2012285504
• Status: Completed
• Phase: N/A
• Start date: June 3, 2021
• Est. completion date: July 7, 2023

Study information

• Verified date: September 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: July 7, 2023
• Est. primary completion date: July 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Wound Heal
• Wounds and Injuries

Intervention

Device:
• Electroceutical Dressing Technology-EDThi
Use of EDThi for 3 weeks post enrollment
• Adding EDTlo (Procellera®) for 3 weeks after use of EDThi
Use of EDTlo (Procellera®) for additional 3 weeks

Locations

Country	Name	City	State
United States	Eskenazi Health	Indianapolis	Indiana
United States	Indiana University Health Methodist Hospital	Indianapolis	Indiana
United States	Richard L. Roudebush VA Medical Center	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	Naval Medical Research Center, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to the use of EDT treatment in prevention of wound biofilm infection	Impact of EDT treatment in prevention of incidence of wound biofilm infection	6 weeks
Secondary	rate of wound closure 6 weeks post-treatment as compared to baseline	rate of wound closure 6 weeks post-treatment as compared to baseline	6 weeks
Secondary	wound microbiome in SoC and SoC+ EDT treatment.	presence of microbiome in standard of care with and w/o treatment	3 weeks
Secondary	Percent of patients with response to EDT treatment on week 6 as compared to SoC only group	Percent of patients showing treatment response on week 6 comparing SOC group to ntervention group	6 weeks