1. This study is a pilot feasibility study to determine treatment effects to estimate sample size for future studies that evaluate wound bacteria colonization. 2. The secondary objective of this study aims to observe the effect of PED on an open wound and its effects in wound bacteria colonization.
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.
Study Type
OBSERVATIONAL
No Interventions
IU Health Methodist Hospital
Indianapolis, Indiana, United States
Bacterial colonization & culture
Bacteria colonization (cultures results high, moderate, low or negative).
Time frame: 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.
Time frame: 3 weeks or until amputation, whichever comes first
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.
Time frame: 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.
Time frame: 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.
Time frame: 3 weeks or until amputation, whichever comes first
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