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Effect of Photodynamic Treatment on Skin Microbiome. Single Center Study (PHOMIC)

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ClinicalTrials.gov Identifier: NCT04067843
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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.

Condition or disease Intervention/treatment Phase
Postoperative Wound Infection Deep Incisional Surgical Site Prosthesis and Implants Surgical Site Infection Prosthetic Joint Infection Procedure: Photodynamic treatment Not Applicable

Detailed Description:

Background. Periprosthetic joint infections are increasing due to our elderly population with the need of a joint prosthesis. These infections are difficult to treat, because bacteria are able to be sessile (biologically inactive) in the biofilms formed within one day on the orthopedic implant surface. Notably, the current available antibiotics do not penetrate the biofilm or are not active against the sessile form of bacteria - rifampicin being the only antibiotic being active. Therefore, prevention is key. In the current paradigm, bacteria from the skin surface or dermis - such as Staphylococcus aureus, coagulase-negative staphylococci, or Cutibacterium sp. - contaminate the peri-implant tissue during surgery. In an ongoing study with the Orthopedic University Hospital Balgrist (manuscript in preparation), the investigators found that the common practice of skin antisepsis is ineffective to eliminate skin bacteria before surgery. Strikingly, the skin bacteria hide in sebaceous or sweat glands. Photodynamic treatment has recently gained attention in the treatment of acne patients, a disease of the pilosebaceous unit, in which also Cutibacterium acnes is implicated. The photodynamic treatment works here on the one hand through a long-lasting destruction of the sebaceous glands, and on the other hand due to anti-inflammatory and antimicrobial effects.

Hypothesis. The investigators hypothesize that photodynamic treatment improves skin antisepsis before surgical implantation of foreign material by reduction of persistent skin colonizing bacteria through the destruction of the sebaceous and sweat glands and by its bactericidal effects Overall and specific objectives. The overarching aim of this research project is to prevent orthopedic implant-associated infections. The specific aim is to evaluate the effect of photodynamic treatment on colonizing bacteria immediately after surgical skin antisepsis (aim 1) and 3 weeks later (aim 2). In aim 3, the investigators will evaluate phylogenetic similarity of same bacterial species before and after photodynamic treatment if they persist.

Methods. The investigators 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. To evaluate phylogenetic similarity of same bacterial species before and after photodynamic treatment, the investigators will investigate the core genome using whole genome sequencing.

Relevance and outlook. The current study will investigate if photodynamic treatment is able to improve preoperative skin preparation to decrease surgical site infections in hip arthroplasty surgery. A decrease of implant-associated infections has multiple benefits, among others reduced morbidity, mortality and lower health costs. This study shall provide the fundament for a prospective cohort study of patients with planned hip arthroplasty for investigating the effect of photodynamic treatment before skin antisepsis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effects of Photodynamic Therapy on the Human Inguinal Skin Microbiome to Improve Antiseptic Effect - a Pilot Study
Actual Study Start Date : August 8, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Photodynamic treatment
Skin microbiome after photodynamic treatment before and after skin antisepsis
Procedure: Photodynamic treatment
Photosensitiser application, followed by fluorescence photography Photodynamic therapy (PHT) (1x) over 15 minutes
Other Name: PDT




Primary Outcome Measures :
  1. 1. Microbiome analysis immediately after photodynamic treatment [ Time Frame: Day 1 ]
    1.1. bacterial density and species before and after photodynamic treatment and antisepsis skin preparation on the same day

  2. 2. Microbiome analysis 3 weeks after photodynamic treatment [ Time Frame: Day 21±3 after PDT treatment ]
    2.1. bacterial density and species after 21 days after photodynamic treatment before and after skin antisepsis


Secondary Outcome Measures :
  1. Phylogenetic comparisons of isolated bacteria [ Time Frame: Day 1 and Day 21 ]
    whole genome sequencing and phylogenetic comparisons of isolated bacteria in different swabs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067843


Contacts
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Contact: Yvonne Achermann, MD 0041 44 255 34 02 yvonne.achermann@usz.ch
Contact: Laurence Imhof 0041 44 255 31 55 laurence.imhof@usz.ch

Locations
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Switzerland
University Hospital of Zurich Recruiting
Zürich, Switzerland
Contact: Yvonne Achermann    0041 44 255 34 02    yvonne.achermann@usz.ch   
Contact: Stefan Kuster       yvonne.achermann@usz.ch   
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Yvonne Achermann, MD University Hospital Zurich, Department of Infectious Diseases and Hospital Epidemiology
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT04067843    
Other Study ID Numbers: 2019-005252
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes