Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04067843 |
Other study ID # |
2019-005252 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 26, 2019 |
Est. completion date |
September 1, 2021 |
Study information
Verified date |
March 2022 |
Source |
University of Zurich |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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 antisepsis strategies for the prevention of surgical
site infections.
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.