Surgical Site Infection Clinical Trial
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04096885 -
The Inselspital Surgical Cohort Study
|
||
Terminated |
NCT03820648 -
Wound Protector Dual-ring Alexis® in Pancreaticoduodenectomy
|
N/A | |
Terminated |
NCT04042077 -
Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections
|
Phase 3 | |
Completed |
NCT05841576 -
Anaesthetic Management Guided by COMET Measurements
|
N/A | |
Withdrawn |
NCT05338281 -
NPWT for Abdominal Incisions in DIEP Reconstructions: A RCT
|
N/A | |
Recruiting |
NCT03042091 -
Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery
|
Early Phase 1 | |
Completed |
NCT01697748 -
Prospective Study on Cesarean Wound Outcomes
|
N/A | |
Terminated |
NCT01789697 -
Text Message Study
|
N/A | |
Recruiting |
NCT05966961 -
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
|
||
Recruiting |
NCT05077592 -
Addition of Pre-wound Closure Povidone Iodine Wash Versus Direct Wound Closure Effect on Surgical Site Infections
|
Phase 4 | |
Recruiting |
NCT05763602 -
PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study)
|
Phase 4 | |
Recruiting |
NCT05502380 -
Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery
|
Phase 3 | |
Recruiting |
NCT03221023 -
Intrawound Vancomycin Prophylaxis for Neural Stimulator
|
Phase 2/Phase 3 | |
Completed |
NCT03257202 -
Topical Treatment and Prevalence of P. Acnes
|
Phase 2 | |
Completed |
NCT06154720 -
Surgical Site Infection After Episiotomy Repair Related to Routine Use of Antibiotic Prophylaxis in Low-Risk Population
|
||
Not yet recruiting |
NCT06465901 -
A Stratified, Multi-ARm, muLti-site Randomised Platform Trial Aiming to Reduce the INcidence of Post-operative SSI
|
N/A | |
Not yet recruiting |
NCT04820075 -
Efficacy of an Intervention to Improve the Preoperative Shower in Scheduled Surgery
|
N/A | |
Recruiting |
NCT03561376 -
Zinc Oxide Versus Petrolatum Following Skin Surgery
|
Early Phase 1 | |
Not yet recruiting |
NCT04496180 -
Prevena to Prevent Surgical Site Infection After Emergency Abdominal Laparotomy
|
N/A | |
Recruiting |
NCT04676841 -
Wound Contamination During Orthopaedic Surgery
|