CompletedNot Applicable

Effect of Photodynamic Therapy on Skin Microbiome. Single Center Study (PHOMIC-II)

Switzerland20 participantsStarted 2021-01-15

Plain-language 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.

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Patients With no Growth of Bacteria on the Skin

Timeframe: Day 0 after PDT

Number of Patients With no Growth of Bacteria on the Skin on After 1 Day

Timeframe: Day 1 after PDT

Number of Patients With no Growth of Bacteria on the Skin After 3 Days

Timeframe: Day 3 after PDT

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

Timeframe: Day 5

Trial details

NCT IDNCT04618276

SponsorUniversity of Zurich

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06-24

Results submitted2024-01-25

View on ClinicalTrials.gov More Postoperative Wound Infection Deep Incisional Surgical Site trials