Prosthesis and ImplantsEarly Phase 1NCT05676801
Effect of Photodynamic Therapy on Skin Microbiome. Single Center Study (PHOMIC-III)
A Early Phase 1 study testing Photodynamic Therapy in people with Prosthesis and Implants and Surgical Site Infection, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthesis and Implants, Surgical Site Infection, Prosthetic Joint Infection
- What is being tested?
- Photodynamic Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Feb 2023to 31 Dec 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female participants ≥ 18 years who volunteer for the pilot study, in which a routine photodynamic treatment at the Department of Dermatology will be performed and effect of skin colonization will be analyzed, and who signed an informed consent (after information about the project)
Who cannot join
- Pregnant and breastfeeding 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 Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital of Zurich
Zurich, 8091
Yvonne Achermann, +41 44 396 74 18, yvonne.achermann@usz.ch
About this study
Official title: Effects of Photodynamic Therapy on the Human Inguinal Skin Microbiome to Improve Antiseptic Effect - Pilot 3
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.
Read the detailed description
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 interdisciplinary study with the Orthopedic University Hospital Balgrist, the investigators see that common skin antisepsis preparation is not effective to eliminate skin bacteria before surgery because they might persist in sebaceous or sweat glands. Photodynamic therapy (PDT) has the potential to improve skin antisepsis as we recently showed. 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 bactericidal effects.
In a previous pilot study, the investigators tested if skin antisepsis can be improved with previous PDT using the photosensitizer-inducing prodrug 5% topical methyl aminolevulinate (MAL) on inguinal skin in 10 healthy participants. The induced photosensitizer was protoporphyrin IX (Pp IX) activated by red light (633 nm). The investigators showed 100% killing 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 the side effects of skin erythema for a few days.
In a follow up study, the investigators tested the PDT effect using 5-aminolevulinic acid (5-ALA) induced Pp IX with a daylight lamp (400-750nm) and achieved 70% skin sterility with skin redness only in a minority of participants. The sterilizing effect lasted up to 3 days.
The investigators are entirely convinced about this novel prevention concept using daylight but need to identify the photosensitizer with the ideal balance of bactericidal effect versus skin irritation. Building upon the gathered data, the investigators will explore PDT with longer incubation time of the photosensitizer MAL and the less toxic and pain free illumination with daylight.
Primary outcome:
Effect of photodynamic therapy with the photosensitizer Pp IX (MAL) and daylight in combination with surgical skin antisepsis on bacterial skin colonization on the day of application and on day 3 after PDT.
- Conditions
- Prosthesis and Implants, Surgical Site Infection, Prosthetic Joint Infection, Postoperative Wound Infection Deep Incisional Surgical Site
- Being tested
- Photodynamic Therapy
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic TherapyDrug
PDT with methyl aminolevulinate (MAL) as the prodrug for the photosensitizer Pp IX
| Study group | Role | What they receive |
|---|---|---|
| PDT group | Experimental | PDT with 5% topical methyl aminolevulinate (MAL) before skin antisepsis Receives: Drug: Photodynamic Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Culture results of skin swabs
Quantitative evaluation of bacterial density and species from skin swabs taken before PDT, immediately after PDT, and after after skin antisepsis using culture technique
Measured: within 10 days after PDT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start4 Feb 2023
- Primary completion1 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis and ImplantsStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients get Photodynamic treatment in addition to skin antisepsis. (The contrallateral side of the leg is our control side, therefore only one arm)
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yvonne Achermann, PD Dr. med., Principal investigator, Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676801
- Sponsor's protocol ID
- 2022_PHOMIC-III
- Status last verified
- May 2023
- First submitted
- 22 Dec 2022
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Photodynamic Therapy on the Human Inguinal Skin Microbiome to Improve Antiseptic Effect - Pilot 3
- ClinicalTrials.gov ID
- NCT05676801
- Acronym / sponsor ID
- 2022_PHOMIC-III
- Conditions
- Prosthesis and Implants, Surgical Site Infection, Prosthetic Joint Infection, Postoperative Wound Infection Deep Incisional Surgical Site
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 4 Feb 2023 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 interdisciplinary study with the Orthopedic University Hospital Balgrist, the investigators see that common skin antisepsis preparation is not effective to eliminate skin bacteria before surgery because they might persist in sebaceous or sweat glands. Photodynamic therapy (PDT) has the potential to improve skin antisepsis as we recently showed. 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 bactericidal effects.
In a previous pilot study, the investigators tested if skin antisepsis can be improved with previous PDT using the photosensitizer-inducing prodrug 5% topical methyl aminolevulinate (MAL) on inguinal skin in 10 healthy participants. The induced photosensitizer was protoporphyrin IX (Pp IX) activated by red light (633 nm). The investigators showed 100% killing 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 the side effects of skin erythema for a few days.
In a follow up study, the investigators tested the PDT effect using 5-aminolevulinic acid (5-ALA) induced Pp IX with a daylight lamp (400-750nm) and achieved 70% skin sterility with skin redness only in a minority of participants. The sterilizing effect lasted up to 3 days.
The investigators are entirely convinced about this novel prevention concept using daylight but need to identify the photosensitizer with the ideal balance of bactericidal effect versus skin irritation. Building upon the gathered data, the investigators will explore PDT with longer incubation time of the photosensitizer MAL and the less toxic and pain free illumination with daylight.
Primary outcome:
Effect of photodynamic therapy with the photosensitizer Pp IX (MAL) and daylight in combination with surgical skin antisepsis on bacterial skin colonization on the day of application and on day 3 after PDT.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients get Photodynamic treatment in addition to skin antisepsis. (The contrallateral side of the leg is our control side, therefore only one arm)
| Arm | Type | Receives |
|---|---|---|
| PDT group | Experimental | Drug: Photodynamic TherapyPDT with 5% topical methyl aminolevulinate (MAL) before skin antisepsis |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy male and female participants ≥ 18 years who volunteer for the pilot study, in which a routine photodynamic treatment at the Department of Dermatology will be performed and effect of skin colonization will be analyzed, and who signed an informed consent (after information about the project)
Key exclusion criteria (8 listed)
- Pregnant and breastfeeding 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 Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) within the 14 days prior and after the PDT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photodynamic TherapyPDT with methyl aminolevulinate (MAL) as the prodrug for the photosensitizer Pp IX | Drug | PDT group |
Primary outcome
Culture results of skin swabs
Time frame: within 10 days after PDT
Quantitative evaluation of bacterial density and species from skin swabs taken before PDT, immediately after PDT, and after after skin antisepsis using culture technique
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvonne Achermann, PD Dr. med. principal investigator
Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Photodynamic Therapy in people with Prosthesis and Implants and Surgical Site Infection, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yvonne Achermann, PD Dr. med. (+41 44 396 74 18, yvonne.achermann@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Culture results of skin swabs (time frame: within 10 days after PDT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.