Powder Topical Rifampicin on Reducing Infections After Neural Tube Defect Surgery in Infants
NCT ID: NCT03198819
Last Updated: 2017-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
30 participants
OBSERVATIONAL
2016-08-31
2017-12-31
Brief Summary
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Detailed Description
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In this study, researchers will be investigated whether prophylactic topical RIF applied on a pre-operative mesh in newborns with open NTD reduce the rate of SSIs and meningitis/ VP shunt infections after surgery. For deep incisional primary SSIs will be evaluated according to the diagnostic criteria of the United States (U.S.) Centers for Disease Control and Prevention (CDC) (1). The diagnosis of VP shunt infections will be made after extensive clinical and laboratory evaluations. the diagnosis of to make shunt infections, criteria of the Hydrocephalus Clinical Research Network (HCRN) will be taken into consideration (2).
Topical RIF Application Procedure The NTD site will be covered with a sterile gauze dressing in the first hours of life after birth in all babies with open NTDs. Then, 10 mg/kg/day RIF will be added to 24 ml of saline (0,9% NaCl), and this will be applied to the mesh as an infusion at a 1cc/h speed . Every day, the same dose of RIF will be delivered to the mesh,changed daily, as a 24-hour infusion until the patient could be operated. After the patient is operated, the RIF infusion delivered to the mesh will be stopped. The cefotaxime treatment will be continued until 72 hours post-op (3).
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Rifampisin group
Researchers will administer topical Rifampicin and intravenous cefotaxime
1. For Rifampicin; 10 mg/kg/day, 24 h infusion on defect area during 3 days
2. For cefotaxime; 50 mg/kg/day, twice a day, intravenous during 5 days.
Local Rifampisin and İnrtravenous cefotaxime
Control group
Researchers will only administer intravenous cefotaxime
1\) Doses; 50 mg/kg/day, twice a day, intravenous during 5 days.
Local Rifampisin and İnrtravenous cefotaxime
Interventions
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Local Rifampisin and İnrtravenous cefotaxime
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Day
28 Days
ALL
No
Sponsors
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Yuzuncu Yıl University
OTHER
Responsible Party
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nihat demir
M.D
Principal Investigators
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nihat demir
Role: STUDY_DIRECTOR
yüzüncüyıl üniversitesi
Locations
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Yuzuncu yil medical school
Van, Outside of the US, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Garner JS, Jarvis WR, Emori TG, Horan TC, Hughes JM. CDC definitions for nosocomial infections, 1988. Am J Infect Control. 1988 Jun;16(3):128-40. doi: 10.1016/0196-6553(88)90053-3.
Beckman JM, Amankwah EK, Tetreault LL, Tuite GF. Reduction in CSF shunt infection over a 10-year period associated with the application of concentrated topical antibiotic powder directly to surgical wounds prior to closure. J Neurosurg Pediatr. 2015 Dec;16(6):648-61. doi: 10.3171/2014.12.PEDS13675. Epub 2015 Sep 18.
Demir N, Peker E, Gulsen I, Kocaman S, Tuncer O, Kirimi E. Powder Topical Rifampin for Reducing Infections After Neural Tube Defect Surgery in Infants. World Neurosurg. 2016 Nov;95:165-170. doi: 10.1016/j.wneu.2016.07.092. Epub 2016 Aug 6.
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