NCT04794621

Electroceutical Dressing Technology (EDT) Against Wound Microbial Biofilm Infection

Electroceutical Dressing Technology Against Wound Microbial Biofilm Infection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-06-03
• Primary completion: 2023-07-07
• Completion: 2023-07-07
• First posted: 2021-03-12
• Last updated: 2023-10-03

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study