Postoperative Wound Infection Deep Incisional Surgical Site, Prosthesis and Implants, Prosthetic Joint Infection, Surgical Site Infection
Conditions
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.
Interventions
PROCEDUREPhotodynamic treatment
Photosensitiser application, followed by fluorescence photography Photodynamic therapy (PHT) (1x) over 15 minutes
Sponsors
University of Zurich
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Bacterial Growth Before and After Photodynamic Treatment and After Skin Antisepsis | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phylogenetic Comparisons of Isolated Bacteria | Day 1 and Day 21 | was not performed due to clear results in aim 1 and 2. |
Countries
Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Photodynamic Treatment Skin microbiome analysis after photodynamic treatment before and after skin antisepsis | 10 |
| Control Group No photodynamic treatment: Skin microbiome before and after skin antisepsis without photodynamic treatment | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Control Group | Total | Photodynamic Treatment |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 20 Participants | 10 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Switzerland | 10 Participants | 20 Participants | 10 Participants |
| Sex: Female, Male Female | 7 Participants | 12 Participants | 5 Participants |
| Sex: Female, Male Male | 3 Participants | 8 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
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
Population: was only performed in the photodynamic treatment arm (n=10) and not in the control group
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Photodynamic Treatment | Number of Participants With Bacterial Growth 3 Weeks After Photodynamic Treatment | Bacterial growth before antisepsis | 10 Participants |
| Photodynamic Treatment | Number of Participants With Bacterial Growth 3 Weeks After Photodynamic Treatment | Bacterial growth after antisepsis | 6 Participants |
Primary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Photodynamic Treatment | Number of Participants With Bacterial Growth Before and After Photodynamic Treatment and After Skin Antisepsis | Bacterial growth at baseline | 10 Participants |
| Photodynamic Treatment | Number of Participants With Bacterial Growth Before and After Photodynamic Treatment and After Skin Antisepsis | Bacterial growth after PDT | 3 Participants |
| Photodynamic Treatment | Number of Participants With Bacterial Growth Before and After Photodynamic Treatment and After Skin Antisepsis | Bacterial growth after antisepsis | 0 Participants |
| Control Group | Number of Participants With Bacterial Growth Before and After Photodynamic Treatment and After Skin Antisepsis | Bacterial growth at baseline | 10 Participants |
| Control Group | Number of Participants With Bacterial Growth Before and After Photodynamic Treatment and After Skin Antisepsis | Bacterial growth after PDT | NA Participants |
| Control Group | Number of Participants With Bacterial Growth Before and After Photodynamic Treatment and After Skin Antisepsis | Bacterial growth after antisepsis | 5 Participants |
Secondary
Phylogenetic Comparisons of Isolated Bacteria
was not performed due to clear results in aim 1 and 2.
Time frame: Day 1 and Day 21
Population: Phylogenetic Comparisons of Isolated Bacteria was not performed due to clear results in aim 1 and 2.