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NCT Number: NCT04794621

Electroceutical Dressing Technology (EDT) 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.

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Key information

Conditions

Wound Heal Infections Surgical Wound Wound Infection Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eskenazi Health, Indianapolis, Indiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Electroceutical Dressing Technology-EDThi

Device

Use of EDThi for 3 weeks post enrollment

Other names: Standard Of Care

Adding EDTlo (Procellera®) for 3 weeks after use of EDThi

Device

Use of EDTlo (Procellera®) for additional 3 weeks

Primary outcomes

  1. Response to the use of EDT treatment in prevention of wound biofilm infection

    Time frame: 6 weeks

    Impact of EDT treatment in prevention of incidence of wound biofilm infection

Secondary outcomes

  1. rate of wound closure 6 weeks post-treatment as compared to baseline

    Time frame: 6 weeks

    rate of wound closure 6 weeks post-treatment as compared to baseline

  2. wound microbiome in SoC and SoC+ EDT treatment.

    Time frame: 3 weeks

    presence of microbiome in standard of care with and w/o treatment

  3. Percent of patients with response to EDT treatment on week 6 as compared to SoC only group

    Time frame: 6 weeks

    Percent of patients showing treatment response on week 6 comparing SOC group to ntervention group

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Naval Medical Research Center
  • United States Department of Defense

Registry information

Official study title

Electroceutical Dressing Technology Against Wound Microbial Biofilm Infection

Acronym: EDT BioFilm

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 12, 2021
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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