Electroceutical Dressing Technology (EDT) Against Wound Microbial Biofilm Infection

NCT ID: NCT04794621

Last Updated: 2023-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-03
• Study Completion Date: 2023-07-07

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.

Conditions

Wound Heal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard of Care Only

This will be group 1

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Electroceutical Dressing Technology-EDThi

Intervention Type: DEVICE

Use of EDThi for 3 weeks post enrollment

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

Intervention Type: DEVICE

Use of EDTlo (Procellera®) for additional 3 weeks

Interventions

Electroceutical Dressing Technology-EDThi

Use of EDThi for 3 weeks post enrollment

Intervention Type: DEVICE

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

Use of EDTlo (Procellera®) for additional 3 weeks

Intervention Type: DEVICE

Other Intervention Names

Standard Of Care

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Naval Medical Research Center

FED

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Sashwati Roy

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sashwati Roy, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Eskenazi Health

Indianapolis, Indiana, United States

Richard L. Roudebush VA Medical Center

Indianapolis, Indiana, United States

Indiana University Health Methodist Hospital

Indianapolis, Indiana, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

2012285504

Identifier Type: -

Identifier Source: org_study_id