N/A
N=20
Effect of Photodynamic Treatment on Skin Microbiome. Single Center Study
Postoperative Wound Infection Deep Incisional Surgical Site · Prosthesis and Implants · Surgical Site Infection · Prosthetic Joint Infection
Bottom Line
View on ClinicalTrials.gov: NCT04067843 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Number of Participants With Bacterial Growth Before and After Photodynamic Treatment and After Skin Antisepsis — 10; 10; 3; NA Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Photodynamic treatment (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Zurich
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Bacterial Growth Before and After Photodynamic Treatment and After Skin Antisepsis |
10; 10; 3; NA; 0; 5 | — |
| PRIMARY Number of Participants With Bacterial Growth 3 Weeks After Photodynamic Treatment |
10; 6 | — |
| SECONDARY Phylogenetic Comparisons of Isolated Bacteria |
— | — |
Summary
The overarching aim of this research project is to prevent orthopedic implant-associated infections. This study aims to investigate if photodynamic therapy has an effect on bacterial skin colonization and decrease number of colonizing bacteria associated with sebaceous and sweat glands in order to improve skin antisepsis strategies for the prevention of surgical site infections.
Eligibility Criteria
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 the photodynamic treatment 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 the photodynamic treatment (PDT)
- Participants who had a history of photosensitivity disorder
- Fitzpatrick's skin phototype V-VI
Data sourced from ClinicalTrials.gov (NCT04067843). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.