Infection Clinical Trial
Official title:
Supracondylar Pinning Antibiotic Stewardship (SPAS) Trial
Prospective, multi-center, randomized controlled trial studying infection rate with or without prophylactic antibiotics at the time of closed reduction and percutaneous pinning of pediatric supracondylar humerus fractures.
The goal of the SPAS trial will be to determine the role of prophylactic antibiotics in closed reduction and percutaneous fixation of pediatric supracondylar humerus fractures. The study will be designed as a prospective, double-blinded, two-arm, non-inferiority trial. The control arm will receive standard of care preoperative prophylactic antibiotics. The intervention group will receive a preoperative saline placebo. The primary outcome of the study will be the development of a surgical site infection, including all infections both superficial and deep. Secondary outcomes will include rate and type of post-operative complications in either group, to account for any drug-related adverse outcomes. The hypothesis is that this surgery is safe to perform without prophylactic antibiotics, and the investigators anticipate finding no difference in infection rates between the two groups. Inclusion criteria will consist of an isolated, closed, displaced supracondylar humerus fracture treated with closed reduction and temporary percutaneous pinning. Immunocompromised patients, pathological fractures, open fractures, polytrauma, skeletally mature patients, and those treated primarily with open reduction or those converted to open reduction will be excluded. Because of the low infection rate observed in this type of surgery, the sample size for the study is estimated at 600 patients per arm for adequate power. With a multicenter design, the expectation will be enrollment over the course of 1-2 years with a follow up of approximately 3 months post-surgical intervention per participant. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04529421 -
Assocation Between In-person Instruction and COVID-19 Risk
|
||
| Recruiting |
NCT04081792 -
Optimal Antibiotics for Operated Diabetic Foot Infections
|
N/A | |
| Completed |
NCT04332861 -
Evaluation of Infection in Obstructing Urolithiasis
|
||
| Recruiting |
NCT04674657 -
Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
|
||
| Enrolling by invitation |
NCT05052203 -
Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
|
||
| Recruiting |
NCT00342589 -
New Techniques for Using a Saline Wash as a Diagnostic Tool for Pneumocystis Pneumonia
|
||
| Completed |
NCT03295825 -
Heparin Binding Protein in Early Sepsis Diagnosis
|
N/A | |
| Completed |
NCT03296423 -
Bacillus Calmette-guérin Vaccination to Prevent Infections of the Elderly
|
Phase 4 | |
| Withdrawn |
NCT04217252 -
Clinical Application of High-throughput Sequencing Technology for the Diagnosis of Patients With Severe Infection
|
N/A | |
| Recruiting |
NCT02899143 -
Short-course Antimicrobial Therapy in Sepsis
|
Phase 2 | |
| Recruiting |
NCT02905552 -
Myelodysplasic Syndromes and Risk Factors for Infection
|
N/A | |
| Withdrawn |
NCT02904434 -
Gastrointestinal Implications of Voriconazole Exposure
|
||
| Active, not recruiting |
NCT02768454 -
Antimicrobials Stewardship by Pharmacist
|
N/A | |
| Completed |
NCT02219776 -
Decreasing Infection In Arthroscopic Shoulder Surgery
|
N/A | |
| Completed |
NCT02210169 -
RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates
|
N/A | |
| Recruiting |
NCT02098226 -
Evaluation of MALDI Biotyper CA System for Detection of Gram- and Gram+ Bacteria and Yeasts
|
N/A | |
| Completed |
NCT01846832 -
A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection
|
Phase 3 | |
| Terminated |
NCT01441206 -
Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants
|
Phase 1 | |
| Completed |
NCT01434797 -
Value of PET/CT Imaging in the Diagnosis of Permanent Central Venous Catheters Infection
|
||
| Completed |
NCT01159834 -
Human Papillomavirus (HPV) Vaccination in Barretos (Pio XII Foundation - Barretos Cancer Hospital)
|
N/A |