Effect of Photodynamic Treatment on Skin Microbiome. Single Center Study (PHOMIC)
Primary Purpose
Postoperative Wound Infection Deep Incisional Surgical Site, Prosthesis and Implants, Surgical Site Infection
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Photodynamic treatment
Sponsored by
About this trial
This is an interventional other trial for Postoperative Wound Infection Deep Incisional Surgical Site
Eligibility 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
Sites / Locations
- University Hospital of Zurich
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Photodynamic treatment
Arm Description
Skin microbiome after photodynamic treatment before and after skin antisepsis
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Phylogenetic Comparisons of Isolated Bacteria
was not performed due to clear results in aim 1 and 2.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04067843
Brief Title
Effect of Photodynamic Treatment on Skin Microbiome. Single Center Study
Acronym
PHOMIC
Official Title
Effects of Photodynamic Therapy on the Human Inguinal Skin Microbiome to Improve Antiseptic Effect - a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 26, 2019 (Actual)
Primary Completion Date
December 16, 2019 (Actual)
Study Completion Date
September 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Wound Infection Deep Incisional Surgical Site, Prosthesis and Implants, Surgical Site Infection, Prosthetic Joint Infection
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Photodynamic treatment
Arm Type
Experimental
Arm Description
Skin microbiome after photodynamic treatment before and after skin antisepsis
Intervention Type
Procedure
Intervention Name(s)
Photodynamic treatment
Other Intervention Name(s)
PDT
Intervention Description
Photosensitiser application, followed by fluorescence photography Photodynamic therapy (PHT) (1x) over 15 minutes
Primary Outcome Measure Information:
Title
Number of Participants With Bacterial Growth Before and After Photodynamic Treatment and After Skin Antisepsis
Description
Skin swabs were taken before photodynamic treatment, after photodynamic treatment and after antisepsis for evaluation of bacterial growth on agar plates
Time Frame
Day 1
Title
Number of Participants With Bacterial Growth 3 Weeks After Photodynamic Treatment
Description
Skin swabs were taken 21 days after photodynamic treatment before and after skin antisepsis to evaluate bacterial growth on agar plates
Time Frame
Day 21±3 after PDT treatment
Secondary Outcome Measure Information:
Title
Phylogenetic Comparisons of Isolated Bacteria
Description
was not performed due to clear results in aim 1 and 2.
Time Frame
Day 1 and Day 21
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvonne Achermann, MD
Organizational Affiliation
University Hospital Zurich, Department of Infectious Diseases and Hospital Epidemiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Zurich
City
Zürich
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Photodynamic Treatment on Skin Microbiome. Single Center Study
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