Surgical Site Infection Clinical Trial
Official title:
Effects of Photodynamic Therapy on the Human Inguinal Skin Microbiome to Improve Antiseptic Effect - Pilot 2
Verified date | September 2021 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The overarching aim of this research project is to prevent orthopedic implant-associated infections. This study aims to investigate if PDT has an effect on bacterial skin colonization in order to improve skin antisepsis strategies for the prevention of surgical site infections.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 24, 2021 |
Est. primary completion date | June 24, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - Healthy male and female participants = 18 years who - volunteer for the pilot study in which a routine photodynamic treatment in the Department of Dermatology will be applied and effect of skin colonization will be analyzed, and - an informed consent is signed by the participant (after information about the project). Exclusion Criteria: - Pregnant and lacting women - Participants with inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc., - Participants taking antibiotics in the 14 days prior to PDT or until follow-up at 21 days - Participants who received oral retinoid therapy within the last 6 months - Participants who received anti-inflammatory agents as NSAR within the 14 days prior and after the PDT - Participants taking any photosensitizing drugs within 4 weeks prior to PDT - Participants who had a history of photosensitivity disorder - Fitzpatrick's skin phototype V-VI |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital of Zurich | Zurich |
Lead Sponsor | Collaborator |
---|---|
University of Zurich |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Culture results of skin swabs | Quantitative evaluatuation of bacterial density and species from skin swabs taken before PDT, immeadiately after PDT, and after after skin antisepsis using culture technique | within 10 days after PDT | |
Primary | Culture results of skin swabs | Quantitative evaluatuation of bacterial density and species from skin swabs taken 1 day after PDT before and after skin antisepsis | within 11 days after PDT | |
Primary | Culture results of skin swabs | Quantitative evaluatuation of bacterial density and species from skin swabs taken 3 days after PDT before and after skin antisepsis | within 13 days after PDT | |
Primary | Culture results of skin swabs | Quantitative evaluatuation of bacterial density and species from skin swabs taken 5 days after PDT before and after skin antisepsis | within 15 days after PDT | |
Secondary | Molecular results of skin swabs | Measurement of bacterial growth of colonizing bacteria and quantitative bacterial changes using an RNA based method | within 3 months |
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