Patterned Electric Dressing Effects on Open Wounds (PED)

Gayle Gordillo

Status: Withdrawn

Conditions: Open Wound; Amputation

Treatments: Other: No Interventions

Study type: Observational

Funder types: Other

Identifiers

NCT04018469

1807454805

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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