About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
75 patients with idiopathic normal pressure hydrocephalus (iNPH) arriving for CSF shunt procedure
written informed consent
Disqualifiers
immunosupressive medication
pregnancy
medication sensitizing for light exposure (e.g. doxycycline)
Trial design
Parallel
Treatments tested in this trial
UVC Irradiation
DeviceUVC irradiation of surgical area
Treatment groups
Trial outcomes
Primary outcomes
The antimicrobial effects of UVC light in the edges of the surgical wound and nucleic acid detections
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 outcomes
Safety of UVC radiation
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.
Sponsors and contacts
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