UVC in Prevention of Surgical Wound Infection

NCT07600463 | Not Yet Recruiting DMC

• 2 other identifiers: KUH5252668Dnro Fimea/2024/003070
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Hydrocephalus

Keywords

Surgical infection; Prevention; UVC

Outcome Measures

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.

  *immediately after surgery

Secondary Outcomes (1)

• Safety of UVC radiation

  immediately after surgery

Study Arms (3)

UVC active 265 nm

ACTIVE COMPARATOR

Active UVC light 265 nm

Device: UVC Irradiation

UVC sham

SHAM COMPARATOR

UVC sham

Device: UVC Irradiation

UVC active 275 nm

ACTIVE COMPARATOR

UVC active 275 nm

Device: UVC Irradiation

Interventions

UVC Irradiation DEVICE

UVC irradiation of surgical area

UVC active 265 nm; UVC active 275 nm; UVC sham

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with idiopathic normal pressure hydrocephalus (iNPH) arriving for CSF shunt procedure
• written informed consent

You may not qualify if:

• immunosupressive medication
• pregnancy
• medication sensitizing for light exposure (e.g. doxycycline)

Sponsors & Collaborators

• Ville Leinonen: lead
• Led Future Oy: collaborator

Study Sites (1)

Kuopio University Hospital

Kuopio, Puijonlaaksontie 2, 70210, Finland

Location

Related Publications (15)

• 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.

  PMID: 2868173 BACKGROUND

• 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.

  PMID: 23826224 BACKGROUND

• 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.

  PMID: 22339192 BACKGROUND

• 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.

  PMID: 8787396 BACKGROUND

• 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.

  PMID: 21562405 BACKGROUND

• 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.

  PMID: 16230765 BACKGROUND

• 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.

  PMID: 28121034 BACKGROUND

• 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.

  PMID: 17554701 BACKGROUND

• 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.

  PMID: 20018479 BACKGROUND

• 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.

  PMID: 20506255 BACKGROUND

• 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.

  PMID: 17433492 BACKGROUND

• 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.

  PMID: 27904353 BACKGROUND

• 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.

  PMID: 21208209 BACKGROUND

• 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.

  PMID: 22564833 BACKGROUND

• 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.

  PMID: 26090835 BACKGROUND

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Ville Leinonen, Professor

CONTACT

+358447172303; ville.leinonen@kuh.fi

Paula Walle, MD PhD

CONTACT

+358447176321; paula.walle@kuh.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Randomization 1:1:1 into active UVC 265 nm, active UVC 275 nm and sham.

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: May 20, 2026
• Study Start (Estimated): June 4, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

FI (1)