Patterned Electric Dressing Effects on Open Wounds (PED)
12. april 2022 oppdatert av: Gayle Gordillo
- This study is a pilot feasibility study to determine treatment effects to estimate sample size for future studies that evaluate wound bacteria colonization.
- The secondary objective of this study aims to observe the effect of PED on an open wound and its effects in wound bacteria colonization.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Indiana
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Indianapolis, Indiana, Forente stater, 46202
- IU Health Methodist Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Bacterial colonization & culture
Tidsramme: 3 weeks or until amputation, whichever comes first
|
Bacteria colonization (cultures results high, moderate, low or negative).
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3 weeks or until amputation, whichever comes first
|
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Necrotic tissue assessed through light microscopy of tissue biopsies
Tidsramme: 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.
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3 weeks or until amputation, whichever comes first
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Wound area measured before and after wound treatment
Tidsramme: 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.
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3 weeks or until amputation, whichever comes first
|
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Bacterial biofilm through Scanning Electron Microscopy analysis
Tidsramme: 3 weeks or until amputation, whichever comes first
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Perform scanning electron microscopy to detect bacterial biofilm (high, moderate, low or negative) before and after PED treatment.
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3 weeks or until amputation, whichever comes first
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Bacterial contamination assessed through Colony Forming Units
Tidsramme: 3 weeks or until amputation, whichever comes first
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Colony forming units will be measured from tissue samples and dressings to quantitate bacterial contamination levels at baseline and after PED treatment.
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3 weeks or until amputation, whichever comes first
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Gordillo Gayle, MD, Indiana University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
1. april 2022
Primær fullføring (Forventet)
1. april 2023
Studiet fullført (Forventet)
1. november 2023
Datoer for studieregistrering
Først innsendt
11. mars 2019
Først innsendt som oppfylte QC-kriteriene
11. juli 2019
Først lagt ut (Faktiske)
12. juli 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. april 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. april 2022
Sist bekreftet
1. april 2022
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1807454805
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .