Patterned Electric Dressing Effects on Open Wounds

Withdrawn

• Conditions: Open Wound; Amputation

• Registration Number: NCT04018469
• Lead Sponsor: Gayle Gordillo

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-07-11
• Study First Posted: 2019-07-12
• Status Verified: 2022-04
• Study Start: 2022-04
• Last Update Submitted: 2022-04-12
• Last Update Posted: 2022-04-19
• Primary Completion: 2023-04
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bacterial colonization & culture	3 weeks or until amputation, whichever comes first	Bacteria colonization (cultures results high, moderate, low or negative).
Necrotic tissue assessed through light microscopy of tissue biopsies	3 weeks or until amputation, whichever comes first	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

IU Health Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States