Postoperative Wound Infection Deep Incisional Surgical SitePHOMICNCT04067843
Effect of Photodynamic Treatment on Skin Microbiome. Single Center Study
A study testing Photodynamic treatment 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 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… 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 treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 Sep 2019to 1 Sep 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 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
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 - a Pilot Study
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.
Read the 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.
- Conditions
- Postoperative Wound Infection Deep Incisional Surgical Site, Prosthesis and Implants, Surgical Site Infection, Prosthetic Joint Infection
- Being tested
- Photodynamic treatment
- 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 treatmentProcedure or surgery
Also called PDT
Photosensitiser application, followed by fluorescence photography Photodynamic therapy (PHT) (1x) over 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Photodynamic treatment | Experimental | Skin microbiome after photodynamic treatment before and after skin antisepsis Receives: Procedure: Photodynamic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
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
Measured: Day 21±3 after PDT treatment
Secondary outcomes (1)
Phylogenetic Comparisons of Isolated Bacteria
was not performed due to clear results in aim 1 and 2.
Measured: Day 1 and Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start26 Sep 2019
- Primary completion16 Dec 2019
- Study completion1 Sep 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
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yvonne Achermann, MD, Principal investigator, University Hospital Zurich, Department of Infectious Diseases and Hospital Epidemiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067843
- Sponsor's protocol ID
- 2019-005252
- Other IDs
- 2019
- Acronym
- PHOMIC
- Status last verified
- Mar 2022
- First submitted
- 9 Aug 2019
- Last updated
- 18 May 2022
- 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 18 May 2022. 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 - a Pilot Study
- ClinicalTrials.gov ID
- NCT04067843
- Acronym / sponsor ID
- PHOMIC / 2019-005252
- 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
- 26 Sep 2019 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Posted 18 May 2022
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 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Photodynamic treatment | Experimental | Procedure: Photodynamic treatmentSkin microbiome after photodynamic treatment before and after skin antisepsis |
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
- 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).
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 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
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 treatmentAlso: PDTPhotosensitiser application, followed by fluorescence photography Photodynamic therapy (PHT) (1x) over 15 minutes | Procedure or surgery | Photodynamic treatment |
Primary outcome
Number of Participants With Bacterial Growth Before and After Photodynamic Treatment and After Skin Antisepsis
Time frame: Day 1
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
Time frame: Day 21±3 after PDT treatment
Skin swabs were taken 21 days after photodynamic treatment before and after skin antisepsis to evaluate bacterial growth on agar plates
1 secondary outcome
Phylogenetic Comparisons of Isolated Bacteria
Time frame: Day 1 and Day 21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- 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.
Yvonne Achermann, MD principal investigator
University Hospital Zurich, Department of Infectious Diseases and Hospital Epidemiology
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 treatment 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 18 May 2022. 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 18 May 2022). 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 Participants With Bacterial Growth Before and After Photodynamic Treatment and After Skin Antisepsis (time frame: Day 1). The study lists 2 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 18 May 2022.