An interventional study of Photodynamic treatment in Postoperative Wound Infection Deep Incisional Surgical Site, Prosthesis and Implants and Surgical Site Infection, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-18.
Sponsored by University of Zurich · Not applicable, Interventional, and Other
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.
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.
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This study's enrollment of 20 is below the median of 120 across 4,201 interventional studies indexed under Infections.
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Counted across the registry records on this site, refreshed daily.
Healthy male and female participants ≥ 18 years who
Exclusion Criteria:
Skin microbiome after photodynamic treatment before and after skin antisepsis
Procedure: Photodynamic treatment
Photosensitiser application, followed by fluorescence photography Photodynamic therapy (PHT) (1x) over 15 minutes
Also known as: PDT
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
Time frame: 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
Time frame: Day 21±3 after PDT treatment
Phylogenetic Comparisons of Isolated Bacteria
was not performed due to clear results in aim 1 and 2.
Time frame: Day 1 and Day 21
| Milestone | Photodynamic Treatment | Control Group |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
Skin swabs were taken before photodynamic treatment, after photodynamic treatment and after antisepsis for evaluation of bacterial growth on agar plates
| Participants | Photodynamic Treatment | Control Group |
|---|---|---|
| Bacterial growth at baseline | 10 | 10 |
| Bacterial growth after PDT | 3 | NA |
| Bacterial growth after antisepsis | 0 | 5 |
Skin swabs were taken 21 days after photodynamic treatment before and after skin antisepsis to evaluate bacterial growth on agar plates
| Participants | Photodynamic Treatment |
|---|---|
| Bacterial growth before antisepsis | 10 |
| Bacterial growth after antisepsis | 6 |
was not performed due to clear results in aim 1 and 2.
No measurements were reported for this outcome.
Collected over from baseline until follow up on day 21. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Photodynamic Treatment | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Control Group | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | Photodynamic Treatment | Control Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 10 | 20 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Photodynamic Treatment | Control Group | Total |
|---|---|---|---|
| Female | 5 | 7 | 12 |
| Male | 5 | 3 | 8 |
| Race and Ethnicity Not Collected(Participants) | Photodynamic Treatment | Control Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Photodynamic Treatment | Control Group | Total |
|---|---|---|---|
| Switzerland | 10 | 10 | 20 |
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