Back to results

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

Primary Purpose

Wound Heal

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Electroceutical Dressing Technology-EDThi

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

About this trial

This is an interventional treatment trial for Wound Heal focused on measuring surgical wounds, infected wounds

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Eskenazi Health
Richard L. Roudebush VA Medical Center
Indiana University Health Methodist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care Only

SOC and PED-10 +Procellera

Arm Description

This will be group 1

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

wound microbiome in SoC and SoC+ EDT treatment.

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

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

Full Information

NCT ID

NCT04794621

First Posted

February 25, 2021

Last Updated

September 29, 2023

Sponsor

Indiana University

Collaborators

United States Department of Defense, Naval Medical Research Center

1. Study Identification

Unique Protocol Identification Number

NCT04794621

Brief Title

Electroceutical Dressing Technology (EDT) Against Wound Microbial Biofilm Infection

Acronym

EDT BioFilm

Official Title

Electroceutical Dressing Technology Against Wound Microbial Biofilm Infection

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

June 3, 2021 (Actual)

Primary Completion Date

July 7, 2023 (Actual)

Study Completion Date

July 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indiana University

Collaborators

United States Department of Defense, Naval Medical Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wound Heal

Keywords

surgical wounds, infected wounds

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Participants are assigned to one of two groups in parallel for the duration of the study

Masking

Outcomes Assessor

Masking Description

to avoid bias, the personnel performing the biofilm analysis (Primary outcome) will be blinded towards the study groups.

Allocation

Randomized

Enrollment

112 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard of Care Only

Arm Type

No Intervention

Arm Description

This will be group 1

Arm Title

SOC and PED-10 +Procellera

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Electroceutical Dressing Technology-EDThi

Other Intervention Name(s)

Standard Of Care

Intervention Description

Use of EDThi for 3 weeks post enrollment

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

Use of EDTlo (Procellera®) for additional 3 weeks

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

6 weeks

Title

wound microbiome in SoC and SoC+ EDT treatment.

Description

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

Time Frame

3 weeks

Title

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

Description

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

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sashwati Roy, PhD

Organizational Affiliation

Indiana University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Eskenazi Health

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Richard L. Roudebush VA Medical Center

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Indiana University Health Methodist Hospital

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46228

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Electroceutical Dressing Technology (EDT) Against Wound Microbial Biofilm Infection

We'll reach out to this number within 24 hrs