Electroceutical Dressing Technology (EDT) Against Wound Microbial Biofilm Infection

NCT04794621 | Completed DMC FDA Device

• 1 other identifier: 2012285504
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 3

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.

Conditions

Wound Heal

Keywords

surgical wounds; infected wounds

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  6 weeks

• wound microbiome in SoC and SoC+ EDT treatment.

  3 weeks

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

  6 weeks

Study Arms (2)

Standard of Care Only

NO INTERVENTION

This will be group 1

SOC and PED-10 +Procellera

EXPERIMENTAL

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

Interventions

Electroceutical Dressing Technology-EDThi DEVICE

Use of EDThi for 3 weeks post enrollment

Also known as: Standard Of Care

SOC and PED-10 +Procellera

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

Use of EDTlo (Procellera®) for additional 3 weeks

SOC and PED-10 +Procellera

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• United States Department of Defense: collaborator
• Naval Medical Research Center: collaborator

Study Sites (3)

Eskenazi Health

Indianapolis, Indiana, 46202, United States

Location

Richard L. Roudebush VA Medical Center

Indianapolis, Indiana, 46202, United States

Location

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46228, United States

Location

MeSH Terms

Conditions

Surgical Wound; Wound Infection

Condition Hierarchy (Ancestors)

Wounds and Injuries; Infections

Study Officials

• Sashwati Roy, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: to avoid bias, the personnel performing the biofilm analysis (Primary outcome) will be blinded towards the study groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

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

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 12, 2021
• Study Start: June 3, 2021
• Primary Completion: July 7, 2023
• Study Completion: July 7, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)