Postoperative Infection Rates
Conditions
Keywords
Topical rifampicin, neural tube defects, infection, newborn
Brief 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.
Detailed 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).
Interventions
DRUGLocal Rifampisin and İnrtravenous cefotaxime
Sponsors
Yuzuncu Yil University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
No
Inclusion criteria
* Newborns who have open NTDs
Exclusion criteria
* Healthy newborns
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical site infections | within 30 days | 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. |
| The diagnosis of ventriculoperitoneal (VP) shunt infection | within one month | 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: 1. the identification of organisms on a culture or Gram stain from cerebrospinal fluid (CSF), a wound swab or pseudocyst fluid; 2. wound breakdown with visible shunt hardware; 3. the presence of an abdominal pseudocyst (even in the absence of positive cultures); or 4. positive blood cultures in a baby with a VP shunt. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospitalization | within 6 months | Researchers will evaluate as follows: 1)Length of hospitalization, 1)The cost of hospitalization. |
Countries
Turkey (Türkiye)
Contacts
Primary Contactibrahim deger, MD
Backup Contactnihat demir
Outcome results
None listed