Powder Topical Rifampicin on Reducing Infections After Neural Tube Defect Surgery in Infants

Postoperative Infection Rates Clinical Trial

Official title:

Powder Topical Rifampicin on Reducing Infections After Neural Tube Defect Surgery in Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03198819
• Status: Recruiting
• Phase: N/A
• First received: August 15, 2016
• Last updated: June 20, 2017
• Start date: August 2016
• Est. completion date: December 2017

Study information

• Verified date: June 2017
• Source: Yuzuncu Yil University
• Contact: ibrahim deger, MD
• Phone: +905052710158
• Email: drdeger[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The correct timing and technique of neural tube defect (NTD) repairs significantly decreases the morbidity and mortality of NTD cases. However, infections related to the surgery are still common. We investigated the effects of topical rifampicin (RIF) combined with routine prophylaxis in newborns with open NTD.

Description:

The study will be conducted in the Yuzuncu Yil University neonatal intensive care unit, Van, Turkey. The data of 60 neonates diagnosed with open NTD, who will be underwent surgical intervention between August 2016 and December 2017, will be prospectively evaluated. These cases will be randomised.These neonates are going to divide into two groups: the experimental group and the control group. The experimental group will be consisted of 30 newborns diagnosed with open NTDs, administered topical RIF (10 mg/kg/day, 24 h infusion) and cefotaxime (50 mg/kg/day, two doses, iv), and the control group will be consisted of 30 newborns diagnosed with open NTDs, administered cefotaxime (50 mg/kg/day, two doses).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

Inclusion Criteria:

• Newborns who have open NTDs

Exclusion Criteria:

• Healthy newborns

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Neural Tube Defects
• Postoperative Infection Rates
• Spinal Dysraphism

Intervention

Drug:
• Local Rifampisin and Inrtravenous cefotaxime

Locations

Country	Name	City	State
Turkey	Yuzuncu yil medical school	Van	Outside of the US

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

References & Publications (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;1 — View Citation

Demir N, Peker E, Gülsen 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. — View Citation

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. Erratum in: Am J Infect Control 1988 Aug;16(4):177. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site infections	Deep incisional primary surgical site infections (SSIs) will be evaluated according to the diagnostic criteria of the United States (U.S.) Centers for Disease Control and Prevention (CDC). Accordingly, a diagnosis of infection will be established when fasciae, muscles or deep soft tissues associated with a surgical incision are affected within the first 30 postoperative days or when a foreign body (implant, etc.) leaves at the operation site will be observed within one year after the operation.	within 30 days
Primary	The diagnosis of ventriculoperitoneal (VP) shunt infection	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.; Shunt infection will be defined as follows: the identification of organisms on a culture or Gram stain from cerebrospinal fluid (CSF), a wound swab or pseudocyst fluid; wound breakdown with visible shunt hardware; the presence of an abdominal pseudocyst (even in the absence of positive cultures); or; positive blood cultures in a baby with a VP shunt.	within one month
Secondary	Length of hospitalization	Researchers will evaluate as follows: 1)Length of hospitalization,; 1)The cost of hospitalization.	within 6 months