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Electroceutical Dressing Technology (EDT) Against Wound Microbial Biofilm Infection

NCT04794621 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2023-10-03

No results posted yet for this study

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

Interventions

DEVICE

Electroceutical Dressing Technology-EDThi

Use of EDThi for 3 weeks post enrollment

DEVICE

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

Use of EDTlo (Procellera®) for additional 3 weeks

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Naval Medical Research Center

    collaborator FED

  • Indiana University

    lead OTHER

Principal Investigators

  • Sashwati Roy, PhD · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-03
Primary Completion
2023-07-07
Completion
2023-07-07
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04794621 on ClinicalTrials.gov