Patterned Electric Dressing Effects on Open Wounds (PED)
12 april 2022 uppdaterad 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Observationell
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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Indiana
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Indianapolis, Indiana, Förenta staterna, 46202
- IU Health Methodist Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Bacterial colonization & culture
Tidsram: 3 weeks or until amputation, whichever comes first
|
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
Tidsram: 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.
|
3 weeks or until amputation, whichever comes first
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Wound area measured before and after wound treatment
Tidsram: 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.
|
3 weeks or until amputation, whichever comes first
|
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Bacterial biofilm through Scanning Electron Microscopy analysis
Tidsram: 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.
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3 weeks or until amputation, whichever comes first
|
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Bacterial contamination assessed through Colony Forming Units
Tidsram: 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.
|
3 weeks or until amputation, whichever comes first
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Gordillo Gayle, MD, Indiana University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Förväntat)
1 april 2022
Primärt slutförande (Förväntat)
1 april 2023
Avslutad studie (Förväntat)
1 november 2023
Studieregistreringsdatum
Först inskickad
11 mars 2019
Först inskickad som uppfyllde QC-kriterierna
11 juli 2019
Första postat (Faktisk)
12 juli 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
19 april 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 april 2022
Senast verifierad
1 april 2022
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1807454805
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .