HydrocephalusUVCJASNCT07600463
UVC in Prevention of Surgical Wound Infection
A study testing UVC Irradiation in people with Hydrocephalus, run by Ville Leinonen at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hydrocephalus
- What is being tested?
- UVC Irradiation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteFinland
- Study dates
- 4 Jun 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 75 patients with idiopathic normal pressure hydrocephalus (iNPH) arriving for CSF shunt procedure
- written informed consent
Who cannot join
- immunosupressive medication
- pregnancy
- medication sensitizing for light exposure (e.g. doxycycline)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site
Kuopio University Hospital
Kuopio, Puijonlaaksontie 2, 70210
Ville Leinonen, professor, +358447172303, ville.leinonen@pshyvinvointialue.fi
Paula Walle, MD PhD, +358447176321, paula.walle@pshyvinvointialue.fi
About this study
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.
Read the detailed description
The following are recruited for the study:
75 patients undergoing elective CSF shunt surgeries
- Conditions
- Hydrocephalus
- Being tested
- UVC Irradiation
- Keywords
- Surgical infection, Prevention, UVC
- Medical subject headings
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UVC IrradiationDevice
UVC irradiation of surgical area
| Study group | Role | What they receive |
|---|---|---|
| UVC active 265 nm | Active comparator | Active UVC light 265 nm Receives: Device: UVC Irradiation |
| UVC sham | Sham comparator | UVC sham Receives: Device: UVC Irradiation |
| UVC active 275 nm | Active comparator | UVC active 275 nm Receives: Device: UVC Irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: *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.
Measured: immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start4 Jun 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization 1:1:1 into active UVC 265 nm, active UVC 275 nm and sham.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ville Leinonen
- Sponsor type
- University, hospital or other
- Collaborators
- Led Future Oy
- Responsible party
- Sponsor-investigator, Ville Leinonen, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600463
- Sponsor's protocol ID
- KUH5252668
- Other IDs
- Dnro Fimea/2024/003070
- Acronym
- UVCJAS
- Status last verified
- May 2026
- First submitted
- 25 Sep 2024
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Original data can be shared with material transfer agreement.
Publications
Wilson AP, Treasure T, Sturridge MF, Gruneberg RN. A scoring method (ASEPSIS) for postoperative wound infections for use in clinical trials of antibiotic prophylaxis. Lancet. 1986 Feb 8;1(8476):311-3. doi: 10.1016/s0140-6736(86)90838-x.
PubMed 2868173van Walraven C, Musselman R. The Surgical Site Infection Risk Score (SSIRS): A Model to Predict the Risk of Surgical Site Infections. PLoS One. 2013 Jun 27;8(6):e67167. doi: 10.1371/journal.pone.0067167. Print 2013.
PubMed 23826224Dai T, Vrahas MS, Murray CK, Hamblin MR. Ultraviolet C irradiation: an alternative antimicrobial approach to localized infections? Expert Rev Anti Infect Ther. 2012 Feb;10(2):185-95. doi: 10.1586/eri.11.166.
PubMed 22339192Sommer R, Haider T, Cabaj A, Heidenreich E, Kundi M. Increased inactivation of Saccharomyces cerevisiae by protraction of UV irradiation. Appl Environ Microbiol. 1996 Jun;62(6):1977-83. doi: 10.1128/aem.62.6.1977-1983.1996.
PubMed 8787396Vonlanthen R, Slankamenac K, Breitenstein S, Puhan MA, Muller MK, Hahnloser D, Hauri D, Graf R, Clavien PA. The impact of complications on costs of major surgical procedures: a cost analysis of 1200 patients. Ann Surg. 2011 Dec;254(6):907-13. doi: 10.1097/SLA.0b013e31821d4a43.
PubMed 21562405Thai TP, Keast DH, Campbell KE, Woodbury MG, Houghton PE. Effect of ultraviolet light C on bacterial colonization in chronic wounds. Ostomy Wound Manage. 2005 Oct;51(10):32-45.
PubMed 16230765Ploegmakers IB, Olde Damink SW, Breukink SO. Alternatives to antibiotics for prevention of surgical infection. Br J Surg. 2017 Jan;104(2):e24-e33. doi: 10.1002/bjs.10426.
PubMed 28121034McClelland S 3rd, Hall WA. Postoperative central nervous system infection: incidence and associated factors in 2111 neurosurgical procedures. Clin Infect Dis. 2007 Jul 1;45(1):55-9. doi: 10.1086/518580. Epub 2007 May 21.
PubMed 17554701Maverakis E, Miyamura Y, Bowen MP, Correa G, Ono Y, Goodarzi H. Light, including ultraviolet. J Autoimmun. 2010 May;34(3):J247-57. doi: 10.1016/j.jaut.2009.11.011. Epub 2009 Dec 16.
PubMed 20018479Kimura H, Lee C, Hayashi K, Yamauchi K, Yamamoto N, Tsuchiya H, Tomita K, Bouvet M, Hoffman RM. UV light killing efficacy of fluorescent protein-expressing cancer cells in vitro and in vivo. J Cell Biochem. 2010 Aug 15;110(6):1439-46. doi: 10.1002/jcb.22693.
PubMed 20506255Kanerva M, Blom M, Tuominen U, Kolho E, Anttila VJ, Vaara M, Virolainen-Julkunen A, Lyytikainen O. Costs of an outbreak of meticillin-resistant Staphylococcus aureus. J Hosp Infect. 2007 May;66(1):22-8. doi: 10.1016/j.jhin.2007.02.014. Epub 2007 Apr 11.
PubMed 17433492Hamidi-Oskouei AM, James C, James S. The Efficiency of UVC Radiation in the Inactivation of Listeria monocytogenes on Beef-Agar Food Models. Food Technol Biotechnol. 2015 Jun;53(2):231-236. doi: 10.17113/ftb.53.02.15.3966.
PubMed 27904353Dai T, Kharkwal GB, Zhao J, St Denis TG, Wu Q, Xia Y, Huang L, Sharma SK, d'Enfert C, Hamblin MR. Ultraviolet-C light for treatment of Candida albicans burn infection in mice. Photochem Photobiol. 2011 Mar-Apr;87(2):342-9. doi: 10.1111/j.1751-1097.2011.00886.x. Epub 2011 Feb 10.
PubMed 21208209Dai T, Garcia B, Murray CK, Vrahas MS, Hamblin MR. UVC light prophylaxis for cutaneous wound infections in mice. Antimicrob Agents Chemother. 2012 Jul;56(7):3841-8. doi: 10.1128/AAC.00161-12. Epub 2012 May 7.
PubMed 22564833Abdullah KG, Attiah MA, Olsen AS, Richardson A, Lucas TH. Reducing surgical site infections following craniotomy: examination of the use of topical vancomycin. J Neurosurg. 2015 Dec;123(6):1600-4. doi: 10.3171/2014.12.JNS142092. Epub 2015 Jun 19.
PubMed 26090835
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UVC in Prevention of Surgical Wound Infection
- ClinicalTrials.gov ID
- NCT07600463
- Acronym / sponsor ID
- UVCJAS / KUH5252668
- Conditions
- Hydrocephalus
- Keywords
- Surgical infection, Prevention, UVC
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Ville LeinonenUniversity, hospital or other
- Collaborators
- Led Future Oy
- Study start
- 4 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomization 1:1:1 into active UVC 265 nm, active UVC 275 nm and sham.
| Arm | Type | Receives |
|---|---|---|
| UVC active 265 nm | Active comparator | Device: UVC IrradiationActive UVC light 265 nm |
| UVC sham | Sham comparator | Device: UVC IrradiationUVC sham |
| UVC active 275 nm | Active comparator | Device: UVC IrradiationUVC active 275 nm |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 75 patients with idiopathic normal pressure hydrocephalus (iNPH) arriving for CSF shunt procedure
- written informed consent
Key exclusion criteria (3 listed)
- immunosupressive medication
- pregnancy
- medication sensitizing for light exposure (e.g. doxycycline)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UVC IrradiationUVC irradiation of surgical area | Device | UVC active 265 nm, UVC active 275 nm, UVC sham |
Primary outcome
The antimicrobial effects of UVC light in the edges of the surgical wound and nucleic acid detections
Time frame: *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.
1 secondary outcome
Safety of UVC radiation
Time frame: immediately after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Background: PubMed 2868173Wilson AP, Treasure T, Sturridge MF, Gruneberg RN. A scoring method (ASEPSIS) for postoperative wound infections for use in clinical trials of antibiotic prophylaxis. Lancet. 1986 Feb 8;1(8476):311-3. doi: 10.1016/s0140-6736(86)90838-x.
- Background: PubMed 23826224van Walraven C, Musselman R. The Surgical Site Infection Risk Score (SSIRS): A Model to Predict the Risk of Surgical Site Infections. PLoS One. 2013 Jun 27;8(6):e67167. doi: 10.1371/journal.pone.0067167. Print 2013.
- Background: PubMed 22339192Dai T, Vrahas MS, Murray CK, Hamblin MR. Ultraviolet C irradiation: an alternative antimicrobial approach to localized infections? Expert Rev Anti Infect Ther. 2012 Feb;10(2):185-95. doi: 10.1586/eri.11.166.
- Background: PubMed 8787396Sommer R, Haider T, Cabaj A, Heidenreich E, Kundi M. Increased inactivation of Saccharomyces cerevisiae by protraction of UV irradiation. Appl Environ Microbiol. 1996 Jun;62(6):1977-83. doi: 10.1128/aem.62.6.1977-1983.1996.
- Background: PubMed 21562405Vonlanthen R, Slankamenac K, Breitenstein S, Puhan MA, Muller MK, Hahnloser D, Hauri D, Graf R, Clavien PA. The impact of complications on costs of major surgical procedures: a cost analysis of 1200 patients. Ann Surg. 2011 Dec;254(6):907-13. doi: 10.1097/SLA.0b013e31821d4a43.
- Background: PubMed 16230765Thai TP, Keast DH, Campbell KE, Woodbury MG, Houghton PE. Effect of ultraviolet light C on bacterial colonization in chronic wounds. Ostomy Wound Manage. 2005 Oct;51(10):32-45.
- Background: PubMed 28121034Ploegmakers IB, Olde Damink SW, Breukink SO. Alternatives to antibiotics for prevention of surgical infection. Br J Surg. 2017 Jan;104(2):e24-e33. doi: 10.1002/bjs.10426.
- Background: PubMed 17554701McClelland S 3rd, Hall WA. Postoperative central nervous system infection: incidence and associated factors in 2111 neurosurgical procedures. Clin Infect Dis. 2007 Jul 1;45(1):55-9. doi: 10.1086/518580. Epub 2007 May 21.
- Background: PubMed 20018479Maverakis E, Miyamura Y, Bowen MP, Correa G, Ono Y, Goodarzi H. Light, including ultraviolet. J Autoimmun. 2010 May;34(3):J247-57. doi: 10.1016/j.jaut.2009.11.011. Epub 2009 Dec 16.
- Background: PubMed 20506255Kimura H, Lee C, Hayashi K, Yamauchi K, Yamamoto N, Tsuchiya H, Tomita K, Bouvet M, Hoffman RM. UV light killing efficacy of fluorescent protein-expressing cancer cells in vitro and in vivo. J Cell Biochem. 2010 Aug 15;110(6):1439-46. doi: 10.1002/jcb.22693.
- Background: PubMed 17433492Kanerva M, Blom M, Tuominen U, Kolho E, Anttila VJ, Vaara M, Virolainen-Julkunen A, Lyytikainen O. Costs of an outbreak of meticillin-resistant Staphylococcus aureus. J Hosp Infect. 2007 May;66(1):22-8. doi: 10.1016/j.jhin.2007.02.014. Epub 2007 Apr 11.
- Background: PubMed 27904353Hamidi-Oskouei AM, James C, James S. The Efficiency of UVC Radiation in the Inactivation of Listeria monocytogenes on Beef-Agar Food Models. Food Technol Biotechnol. 2015 Jun;53(2):231-236. doi: 10.17113/ftb.53.02.15.3966.
- Individual participant dataSharing planned: Undecided. Original data can be shared with material transfer agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UVC Irradiation in people with Hydrocephalus, run by Ville Leinonen at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ville Leinonen, Professor (+358447172303 ext. +358447172303, ville.leinonen@kuh.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The antimicrobial effects of UVC light in the edges of the surgical wound and nucleic acid detections (time frame: *immediately after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07600463, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.