Patterned Electric Dressing Effects on Open Wounds (PED)

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.

Study Overview

• Status: Withdrawn
• Conditions: Amputation; Open Wound
• Intervention / Treatment: Other: No Interventions

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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • IU Health Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

In this study 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. 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Gayle Gordillo
• Investigators: Principal Investigator: Gordillo Gayle, MD, Indiana University

Publications and helpful links

General Publications

• Costerton JW, Stewart PS, Greenberg EP. Bacterial biofilms: a common cause of persistent infections. Science. 1999 May 21;284(5418):1318-22. doi: 10.1126/science.284.5418.1318.
• Ammons MC, Ward LS, James GA. Anti-biofilm efficacy of a lactoferrin/xylitol wound hydrogel used in combination with silver wound dressings. Int Wound J. 2011 Jun;8(3):268-73. doi: 10.1111/j.1742-481X.2011.00781.x. Epub 2011 Apr 1.
• Douglas LJ. Medical importance of biofilms in Candida infections. Rev Iberoam Micol. 2002 Sep;19(3):139-43.
• Schachter B. Slimy business--the biotechnology of biofilms. Nat Biotechnol. 2003 Apr;21(4):361-5. doi: 10.1038/nbt0403-361. No abstract available.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: March 11, 2019
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (Actual): July 12, 2019

Study Record Updates

• Last Update Posted (Actual): April 19, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: PED Wound Dressing
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 1807454805