Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06055712
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-10-04
First Post:
2023-09-20
Brief Title:
Antibiotic Prophylaxis in Pediatric Open Fractures
Sponsor:
St Louis University
Organization:
St Louis University
Study Overview
Official Title:
Antibiotic Prophylaxis in Pediatric Open Fractures
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research will involve a prospective study on infection rates after grade 1 or 2 open fractures in the skeletally immature pediatric population There will be 3 arms one dose intravenous cefazolin 24 hours intravenous cefazolin and 24 hours intravenous cefazolin plus 5 days of oral cephalexin
Detailed Description:
Pediatric patients presenting with open fractures will be screened for eligibility at the time of presentation Informed consent form discussion will take place within 8 hours of the patients presentation or before their second dose of antibiotics would be due if randomized to group 2 or 3
Upon arrival to the ED with an open fracture grade I or II the patient is assessed and care is initiated based on patient presentation Patients are given an IV for medication administration and receive the first dose of antibiotics cefazolin as soon as possible This is standard of care
Treatment of the fracture includes irrigation with saline at least 1 liter depending on wound size The fracture then needs to be stabilized and wound closed Patients are taken to the trauma room typically within 8 hours of presentation for sedation and closed reduction of the fracture These practices are standard of care
If the patient and guardian consent to the study the patient will be randomized to one of three study arms
A one dose of IV cefazolin B 24 hours IV cefazolin 3 doses Q8hrs C 24 hours IV cefazolin 3 doses Q8hrs plus 5 days oral cephalexin
Patients in group A will have no further antibiotic administration assuming they received their first and only dose as soon as possible upon arrival Patients in groups B and C will need to receive their second doses of IV cefazolin 8 hours after administration of the first dose This is why we plan to consent the patientsguardians within 8 hours of presentation
Aside from antibiotic administration all other treatment will be standard of care Patients will undergo closed reduction and any other medical management deemed necessary Prior to discharge participants will be educated on how to identify symptoms of infection It is standard of care to discuss this during discharge education
Frequency of follow up will be determined by standard of care treatment plan for age and fracture type This is at the discretion of the physician Typical follow up is at 1 week then 1 or 2 week intervals for up to 8-12 weeks Study team members will check the patients medical record for indication of infection or adverse events at each follow-up visit If no follow up is reported after three months study staff will conduct a phone interview to collect this data
Upon arrival to the ED with an open fracture grade I or II the patient is assessed and care is initiated based on patient presentation Patients are given an IV for medication administration and receive the first dose of antibiotics cefazolin as soon as possible This is standard of care
Treatment of the fracture includes irrigation with saline at least 1 liter depending on wound size The fracture then needs to be stabilized and wound closed Patients are taken to the trauma room typically within 8 hours of presentation for sedation and closed reduction of the fracture These practices are standard of care
If the patient and guardian consent to the study the patient will be randomized to one of three study arms
A one dose of IV cefazolin B 24 hours IV cefazolin 3 doses Q8hrs C 24 hours IV cefazolin 3 doses Q8hrs plus 5 days oral cephalexin
Patients in group A will have no further antibiotic administration assuming they received their first and only dose as soon as possible upon arrival Patients in groups B and C will need to receive their second doses of IV cefazolin 8 hours after administration of the first dose This is why we plan to consent the patientsguardians within 8 hours of presentation
Aside from antibiotic administration all other treatment will be standard of care Patients will undergo closed reduction and any other medical management deemed necessary Prior to discharge participants will be educated on how to identify symptoms of infection It is standard of care to discuss this during discharge education
Frequency of follow up will be determined by standard of care treatment plan for age and fracture type This is at the discretion of the physician Typical follow up is at 1 week then 1 or 2 week intervals for up to 8-12 weeks Study team members will check the patients medical record for indication of infection or adverse events at each follow-up visit If no follow up is reported after three months study staff will conduct a phone interview to collect this data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None