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

NCT05676801 | Unknown Early Phase 1

• 1 other identifier: 2022_PHOMIC-III
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prosthesis and Implants; Surgical Site Infection; Prosthetic Joint Infection; Postoperative Wound Infection Deep Incisional Surgical Site

Outcome Measures

Primary Outcomes (1)

• Culture results of skin swabs

  Quantitative evaluation of bacterial density and species from skin swabs taken before PDT, immediately after PDT, and after after skin antisepsis using culture technique

  within 10 days after PDT

Study Arms (1)

PDT group

EXPERIMENTAL

PDT with 5% topical methyl aminolevulinate (MAL) before skin antisepsis

Drug: Photodynamic Therapy

Interventions

Photodynamic Therapy DRUG

PDT with methyl aminolevulinate (MAL) as the prodrug for the photosensitizer Pp IX

PDT group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male and female participants ≥ 18 years who volunteer for the pilot study, in which a routine photodynamic treatment at the Department of Dermatology will be performed and effect of skin colonization will be analyzed, and who signed an informed consent (after information about the project)

You may not qualify if:

• Pregnant and breastfeeding 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 Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital of Zurich

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Yvonne Achermann, PD Dr. med.

  Dermatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yvonne Achermann, PD Dr. med.

CONTACT

+41 44 396 74 18; yvonne.achermann@usz.ch

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients get Photodynamic treatment in addition to skin antisepsis. (The contrallateral side of the leg is our control side, therefore only one arm)

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 9, 2023
• Study Start: February 4, 2023
• Primary Completion: September 1, 2023
• Study Completion: December 31, 2023
• Last Updated: May 25, 2023

Record last verified: 2023-05

Locations

CH (1)