Hydrocephalus
Conditions
Keywords
Surgical infection, Prevention, UVC
Brief summary
The LF-PODD study investigates the use of UVC (270nm) light in the prevention of surgical wound infections. Three devices are used in the study, two of which are actively producing UVC light (265 and 275 nm) and one device does not produce UVC light at all. The devices are outwardly completely identical and the devices are drawn for the research participants. Volunteers for neurosurgical procedures are selected for the study. Everyone participating in the study will be informed about the research and written consent will be requested. In the study, UVC light is focused on the surgical area at the beginning of the neurosurgical operation, during the operation, the device automatically dispenses UVC light into the air of the surgical area every 20 minutes, and at the end of the surgical procedure, the device delivers a single dose of UVC light to the surgical wound after closing the surgical wound. Study participants are monitored according to the standard treatment protocol and, in particular, the inflammation of the surgical wound is monitored. The results of the study are recorded and analysed using statistical methods.
Detailed description
The following are recruited for the study: 75 patients undergoing elective CSF shunt surgeries
Interventions
DEVICEUVC Irradiation
UVC irradiation of surgical area
Sponsors
Ville Leinonen
Led Future Oy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomization 1:1:1 into active UVC 265 nm, active UVC 275 nm and sham.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 75 patients with idiopathic normal pressure hydrocephalus (iNPH) arriving for CSF shunt procedure * written informed consent
Exclusion criteria
* immunosupressive medication * pregnancy * medication sensitizing for light exposure (e.g. doxycycline)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The antimicrobial effects of UVC light in the edges of the surgical wound and nucleic acid detections | *immediately after surgery | The ability of UVC light to reduce the incidence of LHI pathogens in surgical wounds: The antimicrobial effects of UVC light are investigated from smear samples taken from the edges of the surgical wound and nucleic acid detections, from which live and dead microbes can be determined. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of UVC radiation | immediately after surgery | Potential harm and benefits to surgical wound tissues: The potentially dangerous effects of healthy tissue at the cellular level are investigated from skin and subcutaneous tissue samples from the wound edge 2 mm x 1 cm. |
Countries
Finland
Contacts
CONTACTVille Leinonen, Professor
CONTACTPaula Walle, MD PhD
Outcome results
None listed