Postoperative Infection RatesNCT03198819
Powder Topical Rifampicin on Reducing Infections After Neural Tube Defect Surgery in Infants
An observational study of Postoperative Infection Rates, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Postoperative Infection Rates
- What is being tested?
- Local Rifampisin and İnrtravenous cefotaxime
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2016to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: 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).
Who may be able to join
- Newborns who have open NTDs
Who cannot join
- Healthy newborns
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Yuzuncu yil medical school
Van, Outside of the US, 65250
nihat demir, 5326039081, demirnihat27@hotmail.com
About this study
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.
Read the 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).
- Conditions
- Postoperative Infection Rates
- Being tested
- Local Rifampisin and İnrtravenous cefotaxime
- Keywords
- Topical rifampicin, neural tube defects, infection, newborn
- Medical subject headings
- Neural Tube Defects, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local Rifampisin and İnrtravenous cefotaximeDrug
Also called Only intravenous cefotaxim
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: 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. Receives: Drug: Local Rifampisin and İnrtravenous cefotaxime |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 30 days
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.
Measured: within one month
Secondary outcomes (1)
Length of hospitalization
Researchers will evaluate as follows:
1)Length of hospitalization,
1)The cost of hospitalization.
Measured: within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study startAug 2016
- Primary completionNov 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative Infection RatesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nihat demir, Yuzuncu Yil University
- Investigators
- nihat demir, Study director, yüzüncüyıl üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198819
- Status last verified
- Jun 2017
- First submitted
- 15 Aug 2016
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 2841893Beckman 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.
PubMed 26382185Demir 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.
PubMed 27506408
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Powder Topical Rifampicin on Reducing Infections After Neural Tube Defect Surgery in Infants
- ClinicalTrials.gov ID
- NCT03198819
- Conditions
- Postoperative Infection Rates
- Keywords
- Topical rifampicin, neural tube defects, infection, newborn
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 26 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rifampisin group | – | Drug: Local Rifampisin and İnrtravenous cefotaximeResearchers 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. |
| Control group | – | Drug: Local Rifampisin and İnrtravenous cefotaximeResearchers will only administer intravenous cefotaxime 1) Doses; 50 mg/kg/day, twice a day, intravenous during 5 days. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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).
Key inclusion criteria (1 listed)
- Newborns who have open NTDs
Key exclusion criteria (1 listed)
- Healthy newborns
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local Rifampisin and İnrtravenous cefotaximeAlso: Only intravenous cefotaxim | Drug | Control group, Rifampisin group |
Primary outcome
Surgical site infections
Time frame: 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
Time frame: 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.
1 secondary outcome
Length of hospitalization
Time frame: within 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
- Results publication: PubMed 2841893Garner 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.
- Results publication: PubMed 26382185Beckman 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.
- Results publication: PubMed 27506408Demir 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
nihat demir study director
yüzüncüyıl üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Infection Rates, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ibrahim deger, MD (+905052710158, drdeger@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical site infections (time frame: within 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03198819, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2017.