Wound HealEDT BioFilmNCT04794621
Electroceutical Dressing Technology (EDT) Against Wound Microbial Biofilm Infection
A study testing Electroceutical Dressing Technology-EDThi and Adding EDTlo (Procellera®) for 3 weeks after use of EDThi in people with Wound Heal, run by Indiana University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Heal
- What is being tested?
- Electroceutical Dressing Technology-EDThi and Adding EDTlo (Procellera®) for 3 weeks after use of EDThi
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Jun 2021to 7 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Eskenazi Health
Indianapolis, Indiana, 46202
Richard L. Roudebush VA Medical Center
Indianapolis, Indiana, 46202
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46228
About this study
Official title: Electroceutical Dressing Technology Against Wound Microbial Biofilm Infection
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.
Read the 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
- Being tested
- Electroceutical Dressing Technology-EDThi, Adding EDTlo (Procellera®) for 3 weeks after use of EDThi
- Keywords
- surgical wounds, infected wounds
- Medical subject headings
- Surgical Wound, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroceutical Dressing Technology-EDThiDevice
Also called Standard Of Care
Use of EDThi for 3 weeks post enrollment
Adding EDTlo (Procellera®) for 3 weeks after use of EDThiDevice
Use of EDTlo (Procellera®) for additional 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Electroceutical Dressing Technology-EDThi; Device: Adding EDTlo (Procellera®) for 3 weeks after use of EDThi |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (3)
rate of wound closure 6 weeks post-treatment as compared to baseline
rate of wound closure 6 weeks post-treatment as compared to baseline
Measured: 6 weeks
wound microbiome in SoC and SoC+ EDT treatment.
presence of microbiome in standard of care with and w/o treatment
Measured: 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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start3 Jun 2021
- Primary completion7 Jul 2023
- Study completion7 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Naval Medical Research Center
- Responsible party
- Principal investigator, Dr. Sashwati Roy, Indiana University
- Investigators
- Sashwati Roy, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794621
- Sponsor's protocol ID
- 2012285504
- Acronym
- EDT BioFilm
- Status last verified
- Sep 2023
- First submitted
- 25 Feb 2021
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroceutical Dressing Technology Against Wound Microbial Biofilm Infection
- ClinicalTrials.gov ID
- NCT04794621
- Acronym / sponsor ID
- EDT BioFilm / 2012285504
- Conditions
- Wound Heal
- Keywords
- surgical wounds, infected wounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense, Naval Medical Research Center
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 7 Jul 2023 (actual)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Only | No intervention | –This will be group 1 |
| SOC and PED-10 +Procellera | Experimental | Device: Electroceutical Dressing Technology-EDThi, Device: Adding EDTlo (Procellera®) for 3 weeks after use of EDThiIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroceutical Dressing Technology-EDThiAlso: Standard Of CareUse of EDThi for 3 weeks post enrollment | Device | SOC and PED-10 +Procellera |
| Adding EDTlo (Procellera®) for 3 weeks after use of EDThiUse of EDTlo (Procellera®) for additional 3 weeks | Device | SOC and PED-10 +Procellera |
Primary outcome
Response to the use of EDT treatment in prevention of wound biofilm infection
Time frame: 6 weeks
Impact of EDT treatment in prevention of incidence of wound biofilm infection
3 secondary outcomes
rate of wound closure 6 weeks post-treatment as compared to baseline
Time frame: 6 weeks
wound microbiome in SoC and SoC+ EDT treatment.
Time frame: 3 weeks
Percent of patients with response to EDT treatment on week 6 as compared to SoC only group
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sashwati Roy, PhD principal investigator
Indiana University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroceutical Dressing Technology-EDThi and Adding EDTlo (Procellera®) for 3 weeks after use of EDThi in people with Wound Heal, run by Indiana University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to the use of EDT treatment in prevention of wound biofilm infection (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.