Patterned Electric Dressing Effects on Open Wounds

Study Overview
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Brief Summary
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This study is a pilot feasibility study to determine treatment effects to estimate sample size for future studies that evaluate wound bacteria colonization. The secondary objective of this study aims to observe the effect of PED on an open wound and its effects in wound bacteria colonization.

Detailed Description
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This study is designed as a pilot study where 30 patients receiving a below the knee amputation with at least one open wound on the limb will be enrolled. Patients are identified through medical records. The patients will be selected based on inclusion and exclusion criteria through pre-screening through the Comprehensive Wound Center's Limb Preservation Program and wound physicians/providers at Indiana University. The decision of amputation is made independently of the study and is solely made by the patient and their physician/provider. The provider decides based on the severity of the limb's condition if/when the limb should be amputated and will schedule this surgery with the patient based on current clinical standard of care. Study participation is decided independent of clinical decision. Patients enrolled in the study will wear the Patterned Electric Dressing (PED) on the wound(s) for up to 3 weeks or until amputation, whichever comes first and will have up to a total of 4 study visits.

Official Title
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Patterned Electric Dressing Effects on Open Wounds

Conditions
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Amputation, Open Wound

Intervention / Treatment
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* Other: No Interventions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18 years and older Patients identified to be receiving a non-traumatic below the knee amputation within 3 weeks of enrollment The affected limb to be amputated must have at least one open wound Wound(s) must be able to be covered by 3x3 dressing Subjects willing and able to provide informed consent Exclusion Criteria: Pregnant women Prisoners Individuals lacking consent capacity

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No Interventions|No Interventions|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial colonization & culture | Bacteria colonization (cultures results high, moderate, low or negative). | 3 weeks or until amputation, whichever comes first | 
| Necrotic tissue assessed through light microscopy of tissue biopsies | Hematoxylin and Eosin staining of tissue sections to measure extent of tissue necrosis at baseline and compared to tissue obtained at surgery after PED treatment.% necrotic tissue will be measured. | 3 weeks or until amputation, whichever comes first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound area measured before and after wound treatment | To determine the effect of PED on % wound closure based on wound measurements at baseline and end of PED treatment. | 3 weeks or until amputation, whichever comes first | 
| Bacterial biofilm through Scanning Electron Microscopy analysis | Perform scanning electron microscopy to detect bacterial biofilm (high, moderate, low or negative) before and after PED treatment. | 3 weeks or until amputation, whichever comes first | 
| Bacterial contamination assessed through Colony Forming Units | Colony forming units will be measured from tissue samples and dressings to quantitate bacterial contamination levels at baseline and after PED treatment. | 3 weeks or until amputation, whichever comes first | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PED Wound Dressing