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

Overview

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.

Full Title of Study: “Effects of Photodynamic Therapy on the Human Inguinal Skin Microbiome to Improve Antiseptic Effect – Pilot 2”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 24, 2021

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.

Interventions

  • Other: Photodynamic Therapy
    • PDT with two different photosensitizers

Arms, Groups and Cohorts

  • Experimental: Arm A (MAL group)
    • Skin swab for culture in the groin for baseline PDT with 5% topical methyl aminolevulinate (MAL) as the prodrug for the photosensitizer Pp IX Skin swab for culture Skin antisepsis Skin swab for culture
  • Experimental: Arm B (Methylene Blue group)
    • Skin swab for culture in the groin for baseline PDT with 0.01% methylene blue based photosensitizer (NF-031) Skin swab for culture Skin antisepsis Skin swab for culture
  • No Intervention: Control group
    • Skin swab for culture in the groin for baseline NO PDT Skin antisepsis Skin swab for culture

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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
  • 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
  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Zurich
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.