Amputation Clinical Trial
— PEDOfficial title:
Patterned Electric Dressing Effects on Open Wounds
NCT number | NCT04018469 |
Other study ID # | 1807454805 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | April 2022 |
Est. completion date | November 2023 |
Verified date | April 2022 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 2023 |
Est. primary completion date | April 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | IU Health Methodist Hospital | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Gayle Gordillo |
United States,
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. — View Citation
Costerton JW, Stewart PS, Greenberg EP. Bacterial biofilms: a common cause of persistent infections. Science. 1999 May 21;284(5418):1318-22. Review. — View Citation
Douglas LJ. Medical importance of biofilms in Candida infections. Rev Iberoam Micol. 2002 Sep;19(3):139-43. — View Citation
Schachter B. Slimy business--the biotechnology of biofilms. Nat Biotechnol. 2003 Apr;21(4):361-5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bacterial colonization & culture | Bacteria colonization (cultures results high, moderate, low or negative). | 3 weeks or until amputation, whichever comes first | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 |
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