Clinical trial NCT04018469: Patterned Electric Dressing Effects on Open Wounds
Official title: Patterned Electric Dressing Effects on Open Wounds
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Amputation
Open Wound
Keywords: PED Wound Dressing
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bacterial colonization & culture
timeFrame: 3 weeks or until amputation, whichever comes first
measure: Necrotic tissue assessed through light microscopy of tissue biopsies
timeFrame: 3 weeks or until amputation, whichever comes first
Secondary outcomes:
measure: Wound area measured before and after wound treatment
timeFrame: 3 weeks or until amputation, whichever comes first
measure: Bacterial biofilm through Scanning Electron Microscopy analysis
timeFrame: 3 weeks or until amputation, whichever comes first
measure: Bacterial contamination assessed through Colony Forming Units
timeFrame: 3 weeks or until amputation, whichever comes first
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Health Methodist Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Gordillo Gayle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Douglas LJ. Medical importance of biofilms in Candida infections. Rev Iberoam Micol. 2002 Sep;19(3):139-43.
citation: Schachter B. Slimy business--the biotechnology of biofilms. Nat Biotechnol. 2003 Apr;21(4):361-5. doi: 10.1038/nbt0403-361. No abstract available.