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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04618276
Recruitment Status : Completed
First Posted : November 5, 2020
Last Update Posted : September 14, 2021
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Study Description
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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.

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

Detailed Description:

Background: Periprosthetic joint infections are a feared complication after orthopedic surgery in particular in our increasing elderly population. These infections are usually difficult to treat, because microorganisms persist in biofilms on the orthopedic implant surface. Therefore, it would be desirable to prevent these infections. It is hypothesized that bacteria from the skin surface or dermis - such as Staphylococcus aureus, coagulase-negative staphylococci, or Cutibacterium sp. - are transmitted into the periimplant tissue during surgery. In an ongoing interdisciplinary study with the Orthopedic University Hospital Balgrist (data in preparation for publication), the investigators see that common skin antisepsis preparation is not effective to eliminate skin bacteria before surgery because they persist in sebaceous or sweat glands. Photodynamic therapy (PDT) has recently gained attention in the treatment of acne, a disease of the pilosebaceous unit, in which also Cutibacterium acnes is implicated. The PDT 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.

In a previous pilot study, the investigators tested if skin antisepsis is improved with previous PDT with the photosensitizer-inducing prodrug 5% topical methyl aminolevulinate (MAL) on inguinal skin in 10 participants. The induced photosensitizer was protoporphyrin IX (Pp IX, 635 nm) activated by red light. The investigators showed a complete sterilization of colonizing skin bacteria at the same day after this treatment However, orthopedic surgeons are hesitant to perform an arthroplasty surgery after such a treatment due to skin erythema for a few days.

The investigators are entirely convinced about this novel prevention concept but need to identify the photosensitizer with the ideal balance of antibactericidal effect versus skin irritation. Building upon the data they gathered, they will explore PDT with the Protoporphyrin IX inducing prodrug photosensitizer MAL and the photosensitizer Methylene blue with potentially less local side-effects (skin erythema).

Primary outcome:

Effect of photodynamic treatment with the photosensitizers Pp IX (MAL) and Methylene blue in combination with surgical antisepsis on bacterial skin colonization on the day of application and on day 1, 3, and 5 after PDT.

Secondary outcome:

Effect of PDT on the skin microbiome using molecular techniques.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Intervention group with PDT

  • Arm A will receive the photosensitizer MAL
  • Arm B will receive Methylene blue as photosensitizer for the PDT.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effects of Photodynamic Therapy on the Human Inguinal Skin Microbiome to Improve Antiseptic Effect - Pilot 2
Actual Study Start Date : January 15, 2021
Actual Primary Completion Date : June 24, 2021
Actual Study Completion Date : June 24, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A (MAL group)
  1. Skin swab for culture in the groin for baseline
  2. PDT with 5% topical methyl aminolevulinate (MAL) as the prodrug for the photosensitizer Pp IX
  3. Skin swab for culture
  4. Skin antisepsis
  5. Skin swab for culture
 Other: Photodynamic Therapy
PDT with two different photosensitizers
Experimental: Arm B (Methylene Blue group)
  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
PDT with two different photosensitizers
No Intervention: Control group
  1. Skin swab for culture in the groin for baseline
  2. NO PDT
  3. Skin antisepsis
  4. Skin swab for culture


Outcome Measures
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Primary Outcome Measures :
  1. Culture results of skin swabs [ Time Frame: within 10 days after PDT ]
    Quantitative evaluatuation of bacterial density and species from skin swabs taken before PDT, immeadiately after PDT, and after after skin antisepsis using culture technique

  2. Culture results of skin swabs [ Time Frame: within 11 days after PDT ]
    Quantitative evaluatuation of bacterial density and species from skin swabs taken 1 day after PDT before and after skin antisepsis

  3. Culture results of skin swabs [ Time Frame: within 13 days after PDT ]
    Quantitative evaluatuation of bacterial density and species from skin swabs taken 3 days after PDT before and after skin antisepsis

  4. Culture results of skin swabs [ Time Frame: within 15 days after PDT ]
    Quantitative evaluatuation of bacterial density and species from skin swabs taken 5 days after PDT before and after skin antisepsis


Secondary Outcome Measures :
  1. Molecular results of skin swabs [ Time Frame: within 3 months ]
    Measurement of bacterial growth of colonizing bacteria and quantitative bacterial changes using an RNA based method


Eligibility Criteria
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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 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
Contacts and Locations
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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): NCT04618276


Locations
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Switzerland
University Hospital of Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
More Information
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT04618276    
Other Study ID Numbers: 2020_PHOMIC-II
First Posted: November 5, 2020    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021
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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Infections
Communicable Diseases
Surgical Wound Infection
Wound Infection
 Disease Attributes
Pathologic Processes
Postoperative Complications