Effect of Photodynamic Treatment on Skin Microbiome. Single Center Study

NCT04067843 | Completed Results

• 1 other identifier: 2019-005252
• 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 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Bacterial Growth Before and After Photodynamic Treatment and After Skin Antisepsis

  Skin swabs were taken before photodynamic treatment, after photodynamic treatment and after antisepsis for evaluation of bacterial growth on agar plates

  Day 1

• Number of Participants With Bacterial Growth 3 Weeks After Photodynamic Treatment

  Skin swabs were taken 21 days after photodynamic treatment before and after skin antisepsis to evaluate bacterial growth on agar plates

  Day 21±3 after PDT treatment

Secondary Outcomes (1)

• Phylogenetic Comparisons of Isolated Bacteria

  Day 1 and Day 21

Study Arms (1)

Photodynamic treatment

EXPERIMENTAL

Skin microbiome after photodynamic treatment before and after skin antisepsis

Procedure: Photodynamic treatment

Interventions

Photodynamic treatment PROCEDURE

Photosensitiser application, followed by fluorescence photography Photodynamic therapy (PHT) (1x) over 15 minutes

Also known as: PDT

Photodynamic treatment

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 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital of Zurich

Zurich, Switzerland

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

1-phenyl-3,3-dimethyltriazene

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

yvonne.achermann@usz.ch

+41442553402

Study Officials

• Yvonne Achermann, MD

  University Hospital Zurich, Department of Infectious Diseases and Hospital Epidemiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigator will collect scrapings from the skin surface and quantitatively evaluate bacterial species and density before and after photodynamic treatment in combination with skin antisepsis of povidone-iodine/alcohol, in aim 1 immediately after skin antisepsis, and in aim 2, 21 days after photodynamic treatment. For aim 2, the investigators will additionally evaluate changes of sebaceous and sweat glands after photodynamic treatment using histopathology.

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: August 28, 2019
• Study Start: September 26, 2019
• Primary Completion: December 16, 2019
• Study Completion: September 1, 2021
• Last Updated: May 18, 2022
• Results First Posted: May 18, 2022

Record last verified: 2022-03

Locations

CH (1)