Patterned Electric Dressing Effects on Open Wounds

NCT04018469 | Withdrawn DMC

• 1 other identifier: 1807454805
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.

Conditions

Amputation; Open Wound

Keywords

PED Wound Dressing

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Wound area measured before and after wound treatment

  3 weeks or until amputation, whichever comes first

• Bacterial biofilm through Scanning Electron Microscopy analysis

  3 weeks or until amputation, whichever comes first

• Bacterial contamination assessed through Colony Forming Units

  3 weeks or until amputation, whichever comes first

Interventions

No Interventions OTHER

No Interventions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Pregnant women
• Prisoners
• Individuals lacking consent capacity

Sponsors & Collaborators

• Gayle Gordillo: lead

Study Sites (1)

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (4)

• 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.

  PMID: 21457463 BACKGROUND

• 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.

  PMID: 10334980 BACKGROUND

• Douglas LJ. Medical importance of biofilms in Candida infections. Rev Iberoam Micol. 2002 Sep;19(3):139-43.

  PMID: 12825991 BACKGROUND

• Schachter B. Slimy business--the biotechnology of biofilms. Nat Biotechnol. 2003 Apr;21(4):361-5. doi: 10.1038/nbt0403-361. No abstract available.

  PMID: 12665817 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

wound debrided tissue and tissue biopsy sample

Study Officials

• Gordillo Gayle, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: July 12, 2019
• Study Start: April 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: November 1, 2023
• Last Updated: April 19, 2022

Record last verified: 2022-04

Locations

US (1)