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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| Naval Medical Research Center | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroceutical Dressing Technology-EDThi | Device | Use of EDThi for 3 weeks post enrollment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| rate of wound closure 6 weeks post-treatment as compared to baseline | rate of wound closure 6 weeks post-treatment as compared to baseline | 6 weeks |
| wound microbiome in SoC and SoC+ EDT treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sashwati Roy, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eskenazi Health | Indianapolis | Indiana | 46202 | United States | ||
| Richard L. Roudebush VA Medical Center |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 27, 2023 | Aug 29, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| D014946 | Wound Infection |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D007239 | Infections |
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Participants are assigned to one of two groups in parallel for the duration of the study
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to avoid bias, the personnel performing the biofilm analysis (Primary outcome) will be blinded towards the study groups.
| Adding EDTlo (Procellera®) for 3 weeks after use of EDThi | Device | Use of EDTlo (Procellera®) for additional 3 weeks |
|
presence of microbiome in standard of care with and w/o treatment
| 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 | 6 weeks |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Indiana University Health Methodist Hospital | Indianapolis | Indiana | 46228 | United States |