- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07600463
UVC in Prevention of Surgical Wound Infection (UVCJAS)
May 13, 2026 updated by: Ville Leinonen
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.
Study Overview
Detailed Description
The following are recruited for the study:
75 patients undergoing elective CSF shunt surgeries
Study Type
Interventional
Enrollment (Estimated)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ville Leinonen, Professor
- Phone Number: +358447172303 +358447172303
- Email: ville.leinonen@kuh.fi
Study Contact Backup
- Name: Paula Walle, MD PhD
- Phone Number: +358447176321
- Email: paula.walle@kuh.fi
Study Locations
-
-
Puijonlaaksontie 2
-
Kuopio, Puijonlaaksontie 2, Finland, 70210
- Kuopio University Hospital
-
Contact:
- Ville Leinonen, professor
- Phone Number: +358447172303
- Email: ville.leinonen@pshyvinvointialue.fi
-
Contact:
- Paula Walle, MD PhD
- Phone Number: +358447176321
- Email: paula.walle@pshyvinvointialue.fi
-
Principal Investigator:
- Paula Walle, MD PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: UVC active 265 nm
Active UVC light 265 nm
|
UVC irradiation of surgical area
|
|
Sham Comparator: UVC sham
|
UVC irradiation of surgical area
|
|
Active Comparator: UVC active 275 nm
|
UVC irradiation of surgical area
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
*immediately after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety of UVC radiation
Time Frame: 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.
|
immediately after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- McClelland 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.
- Vonlanthen 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.
- van 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.
- Dai 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.
- Sommer 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.
- Thai 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.
- Ploegmakers 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.
- Maverakis 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.
- Kimura 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.
- Kanerva 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.
- Hamidi-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.
- Dai 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.
- Dai 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.
- Abdullah 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 4, 2026
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2029
Study Registration Dates
First Submitted
September 25, 2024
First Submitted That Met QC Criteria
May 13, 2026
First Posted (Actual)
May 20, 2026
Study Record Updates
Last Update Posted (Actual)
May 20, 2026
Last Update Submitted That Met QC Criteria
May 13, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KUH5252668
- Dnro Fimea/2024/003070 (Other Identifier: Fimea)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Original data can be shared with material transfer agreement.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hydrocephalus
-
University of Kansas Medical CenterWithdrawnLow Pressure Hydrocephalus
-
Göteborg UniversityDepartment of Neurological Surgery, Sahlgrenska University Hospital; Hydrocephalus... and other collaboratorsNot yet recruitingNormal Pressure Hydrocephalus | Normal Pressure Hydrocephalus Patients
-
Mayo ClinicTerminatedNormal Pressure Hydrocephalus PatientsUnited States
-
Umeå UniversityCompleted
-
Umeå UniversityCompletedIdiopathic Normal Pressure Hydrocephalus
-
University Hospital, Basel, SwitzerlandRecruitingIdiopathic Normal Pressure Hydrocephalus (INPH)Switzerland
-
DeepsonbioRecruitingIdiopathic Normal Pressure Hydrocephalus (iNPH)Korea, Republic of
-
Uppsala University HospitalUppsala University; Swedish Society for Medical ResearchCompletedIdiopathic Normal Pressure Hydrocephalus (INPH)Sweden
-
Johns Hopkins UniversityUniversity of Utah; Integra LifeSciences CorporationCompletedIdiopathic Normal Pressure Hydrocephalus (INPH)United States, Canada, Sweden
-
Dokuz Eylul UniversityRecruitingNPH (Normal Pressure Hydrocephalus)Turkey
Clinical Trials on UVC Irradiation
-
University of CalgaryCompleted
-
Bangkok Metropolitan Administration Medical College...Completed
-
King Fahad Medical CityCompletedEstimating Umbilical Venous Catheter Insertion Depth in Newborns Using Weight or Body MeasurementsSaudi Arabia
-
Universidad Complutense de MadridRecruiting
-
Singapore General HospitalCompletedVery Low Birth Weight Infant | Neonatal Hypoglycemia | Extremely Low Birth Weight | Extreme Prematurity,Extremely Low BirthweightSingapore
-
Kenneth RockwoodNova Scotia Health Authority; Research Nova Scotia; Department of Health, Nova...CompletedCOVID-19 Respiratory Infection | Influenza -Like Illness | Respiratory Virus InfectionCanada
-
Fondazione Policlinico Universitario Agostino Gemelli...Completed
-
Princess Anna Mazowiecka Hospital, Warsaw, PolandCompletedAnatomy of the Ductus Venosus | Umbilical Venous CatheterizationPoland
-
Heidelberg UniversityRecruiting
-
University Hospital HeidelbergRecruiting