Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04618276 |
Other study ID # |
2020_PHOMIC-II |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 15, 2021 |
Est. completion date |
June 24, 2021 |
Study information
Verified date |
September 2021 |
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 PDT has an effect on bacterial skin
colonization in order to improve skin antisepsis strategies for the prevention of surgical
site infections.
Description:
Background: Periprosthetic joint infections are a feared complication after orthopedic
surgery in particular in our increasing elderly population. These infections are usually
difficult to treat, because microorganisms persist in biofilms on the orthopedic implant
surface. Therefore, it would be desirable to prevent these infections. It is hypothesized
that bacteria from the skin surface or dermis - such as Staphylococcus aureus,
coagulase-negative staphylococci, or Cutibacterium sp. - are transmitted into the periimplant
tissue during surgery. In an ongoing interdisciplinary study with the Orthopedic University
Hospital Balgrist (data in preparation for publication), the investigators see that common
skin antisepsis preparation is not effective to eliminate skin bacteria before surgery
because they persist in sebaceous or sweat glands. Photodynamic therapy (PDT) has recently
gained attention in the treatment of acne, a disease of the pilosebaceous unit, in which also
Cutibacterium acnes is implicated. The PDT 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.
In a previous pilot study, the investigators tested if skin antisepsis is improved with
previous PDT with the photosensitizer-inducing prodrug 5% topical methyl aminolevulinate
(MAL) on inguinal skin in 10 participants. The induced photosensitizer was protoporphyrin IX
(Pp IX, 635 nm) activated by red light. The investigators showed a complete sterilization of
colonizing skin bacteria at the same day after this treatment However, orthopedic surgeons
are hesitant to perform an arthroplasty surgery after such a treatment due to skin erythema
for a few days.
The investigators are entirely convinced about this novel prevention concept but need to
identify the photosensitizer with the ideal balance of antibactericidal effect versus skin
irritation. Building upon the data they gathered, they will explore PDT with the
Protoporphyrin IX inducing prodrug photosensitizer MAL and the photosensitizer Methylene blue
with potentially less local side-effects (skin erythema).
Primary outcome:
Effect of photodynamic treatment with the photosensitizers Pp IX (MAL) and Methylene blue in
combination with surgical antisepsis on bacterial skin colonization on the day of application
and on day 1, 3, and 5 after PDT.
Secondary outcome:
Effect of PDT on the skin microbiome using molecular techniques.