An interventional study of Electroceutical Dressing Technology-EDThi and Adding EDTlo (Procellera®) for 3 weeks after use of EDThi in Wound Heal, sponsored by Indiana University. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-03.
Sponsored by Indiana University · Not applicable, Interventional, and Treatment
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.
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.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's enrollment of 112 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
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Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.
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Exclusion Criteria:
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.
Device: Electroceutical Dressing Technology-EDThi · Device: Adding EDTlo (Procellera®) for 3 weeks after use of EDThi
Use of EDThi for 3 weeks post enrollment
Also known as: Standard Of Care
Use of EDTlo (Procellera®) for additional 3 weeks
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
Time frame: 6 weeks
rate of wound closure 6 weeks post-treatment as compared to baseline
rate of wound closure 6 weeks post-treatment as compared to baseline
Time frame: 6 weeks
wound microbiome in SoC and SoC+ EDT treatment.
presence of microbiome in standard of care with and w/o treatment
Time frame: 3 weeks
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
Time frame: 6 weeks
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Plan to share: No
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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