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Patterned Electric Dressing Effects on Open Wounds

2019-07-16 10:38:22 | BioPortfolio

Summary

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.

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.

Study Design

Conditions

Amputation

Intervention

No Interventions

Location

IU Health Methodist Hospital
Indianapolis
Indiana
United States
46202

Status

Recruiting

Source

Indiana University

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-07-16T10:38:22-0400

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Medical and Biotech [MESH] Definitions

The part of a limb or tail following amputation that is proximal to the amputated section.

Works about clinical studies in which participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions (as in an interventional study).

A work that reports on the results of a clinical study in which participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions (as in an interventional study).

Conduct and synthesis of systematic research comparing interventions and strategies to prevent, diagnose, treat, and monitor health conditions. The purpose of this research is to inform patients, providers, and decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances. (hhs.gov/recovery/programs/cer/draftdefinition.html accessed 6/12/2009)

Amputation or separation at a joint. (Dorland, 28th ed)

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