N/A
Completed N=20
Effect of Photodynamic Therapy on Skin Microbiome. Single Center Study (PHOMIC-II)
Postoperative Wound Infection Deep Incisional Surgical Site · Prosthesis and Implants · Surgical Site Infection · Prosthetic joint infection
Source: ClinicalTrials.gov NCT04618276 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Number of Patients With no Growth of Bacteria on the Skin — 3; 7; 6; 7 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With no Growth of Bacteria on the Skin |
3; 7; 6; 7 | — |
| PRIMARY Number of Patients With no Growth of Bacteria on the Skin on After 1 Day |
2; 7 | — |
| PRIMARY Number of Patients With no Growth of Bacteria on the Skin After 3 Days |
3; 6 | — |
| PRIMARY Number of Patients With no Growth of Bacteria on the Skin on Day 5 Number of Patients With no Growth of Bacteria on the Skin on Day 5 |
— | — |
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 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
Data sourced from ClinicalTrials.gov (NCT04618276). 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. Informational only — not medical advice.