UVC in Prevention of Surgical Wound Infection

ConditionHydrocephalus
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorVille Leinonen

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • UVC Irradiation

    Device

    UVC irradiation of surgical area

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: UVC active 265 nmActive comparator 1 intervention
Group B: UVC shamSham comparator 1 intervention
Group C: UVC active 275 nmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
*immediately after surgery

Secondary outcomes

1

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.

Time frame
immediately after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ville Leinonen

Lead sponsor

Kuopio University Hospital

Sponsor institution

Led Future Oy

Collaborator

This trial is not recruiting at the moment. You can still explore other options: