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| ID | Type | Description | Link |
|---|---|---|---|
| Dnro Fimea/2024/003070 | Other Identifier | Fimea |
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| Name | Class |
|---|---|
| Led Future Oy | UNKNOWN |
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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.
The following are recruited for the study:
75 patients undergoing elective CSF shunt surgeries
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UVC active 265 nm | Active Comparator | Active UVC light 265 nm |
|
| UVC sham | Sham Comparator | UVC sham |
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| UVC active 275 nm | Active Comparator | UVC active 275 nm |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UVC Irradiation | Device | UVC irradiation of surgical area |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | immediately after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ville Leinonen, Professor | Contact | +358447172303 | +358447172303 | ville.leinonen@kuh.fi |
| Paula Walle, MD PhD | Contact | +358447176321 | paula.walle@kuh.fi |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kuopio University Hospital | Kuopio | Puijonlaaksontie 2 | 70210 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2868173 | Background | 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. | |
| 23826224 | 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. |
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Original data can be shared with material transfer agreement.
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| ID | Term |
|---|---|
| D006849 | Hydrocephalus |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Randomization 1:1:1 into active UVC 265 nm, active UVC 275 nm and sham.
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| 22339192 | 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. |
| 8787396 | 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. |
| 21562405 | 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. |
| 16230765 | 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. |
| 28121034 | 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. |
| 17554701 | 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. |
| 20018479 | 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. |
| 20506255 | 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. |
| 17433492 | 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. |
| 27904353 | 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. |
| 21208209 | 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. |
| 22564833 | 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. |
| 26090835 | 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. |