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

NCT04618276 | Completed Results

• 1 other identifier: 2020_PHOMIC-II
• 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

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

Outcome Measures

Primary Outcomes (4)

• Number of Patients With no Growth of Bacteria on the Skin

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

  Day 0 after PDT

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

  Quantitative evaluatuation of bacterial density and species from skin swabs taken 1 day after PDT before and after skin antisepsis

  Day 1 after PDT

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

  Quantitative evaluatuation of bacterial density and species from skin swabs taken 3 days after PDT before and after skin antisepsis

  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

  Quantitative evaluatuation of bacterial density and species from skin ...

  Day 5

Study Arms (3)

Arm A (5-ALA group)

EXPERIMENTAL

1. Skin swab for culture in the groin for baseline 2. PDT with 5% topical 5-ALA as the prodrug for the photosensitizer Pp IX 3. Skin swab for culture 4. Skin antisepsis 5. Skin swab for culture

Other: Photodynamic Therapy

Arm B (Methylene Blue group)

EXPERIMENTAL

1. Skin swab for culture in the groin for baseline 2. PDT with 0.01% methylene blue based photosensitizer (NF-031) 3. Skin swab for culture 4. Skin antisepsis 5. Skin swab for culture

Other: Photodynamic Therapy

Control group

NO INTERVENTION

1. Skin swab for culture in the groin for baseline 2. NO PDT 3. Skin antisepsis 4. Skin swab for culture

Interventions

Photodynamic Therapy OTHER

PDT with two different photosensitizers

Arm A (5-ALA group); Arm B (Methylene Blue 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 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital of Zurich

Zurich, 8091, Switzerland

Location

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

Results Point of Contact

• Title: PD Dr. med. Yvonne Achermann
• Organization: University Hospital Zurich

yvonne.achermann@usz.ch

+41 44 396 74 18

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention group with PDT * Arm A will receive the photosensitizer 5-ALA * Arm B will receive Methylene blue as photosensitizer for the PDT.

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: November 5, 2020
• Study Start: January 15, 2021
• Primary Completion: June 24, 2021
• Study Completion: June 24, 2021
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-07

Locations

CH (1)