Electroceutical Dressing Technology (EDT) Against Wound Microbial Biofilm Infection (EDT BioFilm)

G
Gayle Gordillo, MD

Primary Investigator

Not Recruiting
18 years or above
All
Phase N/A
112 participants needed
5 Locations

Brief description of study

There are currently limited treatments available that show anti-biofilm efficacy for woundgement Biofilms account for over 80% of infections and approximately 65% ofused by microorganisms in the developed world involve biofilms. Therey is a need for cost effective, highly stable, easily obtained biofilm targetedgies 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 biofilmd efficacy in wound healing and closure. Such knowledge could help therapeuticgies and could provide information for future clinical studies to further understandingDT wound dressings.

Detailed description of study

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 they of EDT dressing against wound biofilm infection. subjects will be randomized to onehe 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 ishieved.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Wound Heal
  • Age: 18 years or above
  • Gender: All

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 adequateupport wound healing per provider discretion, this may be defined by one or morehe following perfusion values within 6 months on enrollment: peri-woundutaneous oxygen measurements ≥ 25 mmHg (TCOM),Ankle Brachial Index (ABI) >0.7,Toe pressure (TP) > 40 mmHg, If none of these tests were performed duringdard of care, then a trained study team member may obtain a TCOM measurement afterhe patient has consented and before they are enrolled. If there are multipleusion values that conflict, then a physician will review and determine if they aregible for enrollment. If a patient has had a recent re-vascularization, the patienty 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 ofhe 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.

Updated on 13 Dec 2024. Study ID: 2012285504

Interested in the study?

Select a study center that’s convenient for you, and get in touch with the study team.

Contact a study center