Procellera® Compared to Standard of Care Treatment in Mitigating Biofilm Formation in Acute Trauma and Burn Wounds

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Randomized, Controlled Study to Determine the Superiority of a Fabric-based Wireless Electroceutical Dressing, Procellera® Compared to Standard of Care Treatment in Mitigating Biofilm Formation in Acute Trauma and Burn Wounds

Conditions
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Trauma-related Wound, Burn, Partial Thickness

Intervention / Treatment
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* Device: Procellera®
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 years of age Willing and able to provide informed consent Participant has acute partial-thickness or full-thickness wounds caused by trauma or partial-thickness burns that are ≥ 300 cm2 in size in one contiguous area or two separate wound sites ≥ 150 cm2 each Exclusion Criteria: Pregnancy Prisoner Active malignancy or immunosuppressive therapy Current systemic steroid use Known allergy or sensitivity to silver or zinc Participant's proposed study wound site has any of the following conditions: Location is on the hands, face or feet Full-thickness burn wounds Exposure of visceral organs Exposure of hardware or prosthetic exposure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will have two wound sites that will be randomized to receive either the standard of care treatment or the Procellera® (electroceutical) dressing.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Procellera® dressing<br>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. | Device: Procellera®<br>* Application of Procellera® dressing.<br>|
| Active Comparator: Standard of Care<br>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. | Other: Standard of Care<br>* Application of standard of care dressings as prescribed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |