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| Name | Class |
|---|---|
| Indiana University | OTHER |
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The objective of the study is to evaluate Procellera® , a novel FDA approved antimicrobial wound dressing in a prospective, randomized, controlled clinical study. The hypothesis is that when the dressing is moistened, the low electric field created by moisture-activated elemental silver and zinc electro-couple will prevent formation of biofilm in wounds or to disrupt existing biofilm.
The healing of traumatic wounds, to include burns, can be compromised by the presence of infection so efforts are made to prevent or diagnose infection early in order to mitigate the negative impact on healing. Electric stimulation has previously been shown to have both bacteriostatic and bactericidal effects in wounds. Until now, administering low intensity electric field/micro-current as a therapy to mitigate biofilm infection and to improve wound healing was not feasible. In this study the investigators will use Procellera® , a FDA approved fabric based wireless electroceutical dressing (WED) consisting of a silver-zinc electro-couple for the prevention of wound biofilm formation. The dressing generates a low electric field (~1V) upon activation by a moist environment, which mitigates biofilm formation and promotes wound healing. The objectives of the study are to evaluate the efficacy of a wireless electroceutical dressing to prevent the formation or disrupting existing biofilms. The investigators will conduct a prospective, randomized controlled clinical trial using the Procellera® dressing compared to the standard of care. Treatment sites will be randomized to either receiving Procellera® or the standard of care treatment. Objective measurements and assessments will be completed during subject follow-up visits for up to one month post treatment. This includes biopsies to calculate bacterial load by assessing colony forming unit (CFU) count and bacterial film visualization using scanning electron microscopy, histology, clinical assessment of infection, Transepidermal Water Loss (TEWL) and wound photography.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Procellera® dressing | Experimental | The Procellera® dressing will be applied to the wound site after standard of care cleaning and debridement. The dressing will be maintained according to the manufacturer's instructions for use. |
|
| Standard of Care | Active Comparator | The Standard of care as prescribed will be followed for the dressing application for the wound site. Dressings will be applied to the wound site after standard of care cleaning and debridement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procellera® | Device | Application of Procellera® dressing. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of biofilm | Presence of biofilm will be assessed by obtaining a wound biopsy and analyzing with Scanning Electron Microscopy. | Day seven |
| Rate of eradication of biofilm production | Presence of biofilm will be assessed by obtaining a wound biopsy and analyzing with Scanning Electron Microscopy. | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of infection | Wounds will be assessed for the presence of clinical evidence indicating infection. | Day 0-30 |
| Percent epithelialization | The percentage of epitheliazation will be assessed utilizing clinical assessments and the Silhouette Star wound camera. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36855334 | Derived | Chan RK, Nuutila K, Mathew-Steiner SS, Diaz V, Anselmo K, Batchinsky M, Carlsson A, Ghosh N, Sen CK, Roy S. A Prospective, Randomized, Controlled Study to Evaluate the Effectiveness of a Fabric-Based Wireless Electroceutical Dressing Compared to Standard-of-Care Treatment Against Acute Trauma and Burn Wound Biofilm Infection. Adv Wound Care (New Rochelle). 2024 Jan;13(1):1-13. doi: 10.1089/wound.2023.0007. Epub 2023 Apr 11. |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Participants will have two wound sites that will be randomized to receive either the standard of care treatment or the Procellera® (electroceutical) dressing.
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Biopsies obtained will be sent to Indiana University for blinded processing and analysis.
| Standard of Care |
| Other |
Application of standard of care dressings as prescribed. |
|
| Day 7 |
| Quality of healing | Quality of healing post-epithelialization as measured by the validated Patient Observer Scar Assessment Scale (POSAS) | Day 30 |
| Quantitative bacterial load calculation | Quantitative bacterial load will be assessed by obtaining a wound biopsy and analyzed by performing colony forming unit counts | Day 7 |
| Incidence of adverse events | The incidence of adverse events will be reported to assess safety. | Day 0-30 |