Electroceutical Dressing Technology (EDT) Against Wound Microbial Biofilm Infection (EDT BioFilm)

Electroceutical Dressing Technology Against Wound Microbial Biofilm Infection

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.

Study Overview

• Status: Completed
• Conditions: Wound Heal
• Intervention / Treatment: Device: Electroceutical Dressing Technology-EDThi; Device: Adding EDTlo (Procellera®) for 3 weeks after use of EDThi

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.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bryce B Hockman, CCRP; Phone Number: 3172782715; Email: bbhockma@iu.edu
• Study Contact Backup: Name: Kaitlyn Depinet, FNP-C; Phone Number: 3172782747; Email: kdepinet@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Eskenazi Health
    • Indianapolis, Indiana, United States, 46202
      • Richard L. Roudebush VA Medical Center
    • Indianapolis, Indiana, United States, 46228
      • Indiana University Health Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care Only; This will be group 1
Experimental: SOC and PED-10 +Procellera; 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® or EDTlo for additional 3 weeks. The use of dressings will be discontinued anytime if complete wound closure is achieved.	Device: Electroceutical Dressing Technology-EDThi; Use of EDThi for 3 weeks post enrollment; Other Names: Standard Of Care; Device: Adding EDTlo (Procellera®) for 3 weeks after use of EDThi; Use of EDTlo (Procellera®) for additional 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
wound microbiome in SoC and SoC+ EDT treatment.	presence of microbiome in standard of care with and w/o treatment	3 weeks
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

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: United States Department of Defense; Naval Medical Research Center
• Investigators: Principal Investigator: Sashwati Roy, PhD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2021
• Primary Completion (Actual): July 7, 2023
• Study Completion (Actual): July 7, 2023

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: March 8, 2021
• First Posted (Actual): March 12, 2021

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: surgical wounds; infected wounds
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 2012285504

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No