NCT04785248 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Choux M, Genitori L, Lang D, Lena G
Shunt implantation: reducing the incidence of shunt infection. J Neurosurg. 1992 Dec;77(6):875-80. Review.
Erps A, Roth J, Constantini S, Lerner-Geva L, Grisaru-Soen G
Risk factors and epidemiology of pediatric ventriculoperitoneal shunt infection. Pediatr Int. 2018 Dec;60(12):1056-1061. doi: 10.1111/ped.13709. Epub 2018 Dec 10.
McGirt MJ, Zaas A, Fuchs HE, George TM, Kaye K, Sexton DJ
Risk factors for pediatric ventriculoperitoneal shunt infection and predictors of infectious pathogens. Clin Infect Dis. 2003 Apr 1;36(7):858-62. Epub 2003 Mar 18.
Rozzelle CJ, Leonardo J, Li V
Antimicrobial suture wound closure for cerebrospinal fluid shunt surgery: a prospective, double-blinded, randomized controlled trial. J Neurosurg Pediatr. 2008 Aug;2(2):111-7. doi: 10.3171/PED/2008/2/8/111.
Working Group on Neurosurgical Outcomes Monitoring, Woo PY, Wong HT, Pu JK, Wong WK, Wong LY, Lee MW, Yam KY, Lui WM, Poon WS
Primary ventriculoperitoneal shunting outcomes: a multicentre clinical audit for shunt infection and its risk factors. Hong Kong Med J. 2016 Oct;22(5):410-9. Epub 2016 Aug 26.
Wu Y, Green NL, Wrensch MR, Zhao S, Gupta N
Ventriculoperitoneal shunt complications in California: 1990 to 2000. Neurosurgery. 2007 Sep;61(3):557-62; discussion 562-3.
Yang YN, Zhang J, Gu Z, Song YL
The risk of intracranial infection in adults with hydrocephalus after ventriculoperitoneal shunt surgery: A retrospective study. Int Wound J. 2020 Jun;17(3):722-728. doi: 10.1111/iwj.13331. Epub 2020 Feb 19.

A Prospective Clinical Observation of Ventriculo-Peritoneal Shunt in Patients With Normal or Low Hydrocephalus and A Multi-Center Randomized Controlled Study on Application of "Three-step Disinfection" in Reducing the Incidence of Post-operative Infection

Details for clinical trial NCT04785248

Clinical trial NCT04785248 - References