Postoperative Wound Infection Deep Incisional Surgical SiteNCT04618276
Effect of Photodynamic Therapy on Skin Microbiome. Single Center Study (PHOMIC-II)
A study testing Photodynamic Therapy in people with Postoperative Wound Infection Deep Incisional Surgical Site and Prosthesis and Implants, 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
- Postoperative Wound Infection Deep Incisional Surgical Site, Prosthesis and Implants, Surgical Site 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
- 15 Jan 2021to 24 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Photodynamic Therapy on the Human Inguinal Skin Microbiome to Improve Antiseptic Effect - Pilot 2
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
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 m5-aminolevulinic acid 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 (5-ALA) 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.
- Conditions
- Postoperative Wound Infection Deep Incisional Surgical Site, Prosthesis and Implants, Surgical Site Infection, Prosthetic Joint Infection
- 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 TherapyOther
PDT with two different photosensitizers
| Study group | Role | What they receive |
|---|---|---|
| Arm A (5-ALA group) | Experimental | 1. Skin swab for culture in the groin for baseline
2. PDT with 5% topical 5-ALA as the prodrug for the photosensitizer Pp IX
3. Skin swab for culture
4. Skin antisepsis
5. Skin swab for culture Receives: Other: Photodynamic Therapy |
| Arm B (Methylene Blue group) | Experimental | 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 Receives: Other: Photodynamic Therapy |
| Control group | No intervention | 1. Skin swab for culture in the groin for baseline 2. NO PDT 3. Skin antisepsis 4. Skin swab for culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With no Growth of Bacteria on the Skin
Quantitative evaluation of bacterial density and species from skin swabs taken before PDT, immeadiately after PDT, and after after skin antisepsis using culture technique
Measured: Day 0 after PDT
Number of Patients With no Growth of Bacteria on the Skin on After 1 Day
Quantitative evaluatuation of bacterial density and species from skin swabs taken 1 day after PDT before and after skin antisepsis
Measured: Day 1 after PDT
Number of Patients With no Growth of Bacteria on the Skin After 3 Days
Quantitative evaluatuation of bacterial density and species from skin swabs taken 3 days after PDT before and after skin antisepsis
Measured: Day 3 after PDT
Number of Patients With no Growth of Bacteria on the Skin on Day 5 Number of Patients With no Growth of Bacteria on the Skin on Day 5
Quantitative evaluatuation of bacterial density and species from skin ...
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start15 Jan 2021
- Primary completion24 Jun 2021
- Study completion24 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative Wound Infection Deep Incisional Surgical SiteStudies 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
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group with PDT * Arm A will receive the photosensitizer 5-ALA * Arm B will receive Methylene blue as photosensitizer for the PDT.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618276
- Sponsor's protocol ID
- 2020_PHOMIC-II
- Status last verified
- Jul 2024
- First submitted
- 21 Oct 2020
- Last updated
- 15 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 15 Oct 2024. 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 2
- ClinicalTrials.gov ID
- NCT04618276
- Acronym / sponsor ID
- 2020_PHOMIC-II
- Conditions
- Postoperative Wound Infection Deep Incisional Surgical Site, Prosthesis and Implants, Surgical Site Infection, Prosthetic Joint Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 24 Jun 2021 (actual)
- Study completion
- 24 Jun 2021 (actual)
- First posted
- 5 Nov 2020 (actual)
- Results
- Posted 15 Oct 2024
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
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 m5-aminolevulinic acid 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 (5-ALA) 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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Intervention group with PDT * Arm A will receive the photosensitizer 5-ALA * Arm B will receive Methylene blue as photosensitizer for the PDT.
| Arm | Type | Receives |
|---|---|---|
| Arm A (5-ALA group) | Experimental | Other: Photodynamic Therapy1. Skin swab for culture in the groin for baseline 2. PDT with 5% topical 5-ALA as the prodrug for the photosensitizer Pp IX 3. Skin swab for culture 4. Skin antisepsis 5. Skin swab for culture |
| Arm B (Methylene Blue group) | Experimental | Other: Photodynamic Therapy1. 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 |
| Control group | No intervention | –1. Skin swab for culture in the groin for baseline 2. NO PDT 3. Skin antisepsis 4. Skin swab for culture |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male and female participants ≥ 18 years who
Key exclusion criteria (8 listed)
- 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
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 two different photosensitizers | Other | Arm A (5-ALA group), Arm B (Methylene Blue group) |
Primary outcome
Number of Patients With no Growth of Bacteria on the Skin
Time frame: Day 0 after PDT
Quantitative evaluation of bacterial density and species from skin swabs taken before PDT, immeadiately after PDT, and after after skin antisepsis using culture technique
Number of Patients With no Growth of Bacteria on the Skin on After 1 Day
Time frame: Day 1 after PDT
Quantitative evaluatuation of bacterial density and species from skin swabs taken 1 day after PDT before and after skin antisepsis
Number of Patients With no Growth of Bacteria on the Skin After 3 Days
Time frame: Day 3 after PDT
Quantitative evaluatuation of bacterial density and species from skin swabs taken 3 days after PDT before and after skin antisepsis
Number of Patients With no Growth of Bacteria on the Skin on Day 5 Number of Patients With no Growth of Bacteria on the Skin on Day 5
Time frame: Day 5
Quantitative evaluatuation of bacterial density and species from skin ...
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photodynamic Therapy in people with Postoperative Wound Infection Deep Incisional Surgical Site and Prosthesis and Implants, 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 3 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: finished, as of the sponsor's last update on 15 Oct 2024. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With no Growth of Bacteria on the Skin (time frame: Day 0 after PDT). The study lists 4 primary outcomes in all. 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 15 Oct 2024.