Infection, Supracondylar Humerus Fracture
Conditions
Keywords
antibiotic stewardship, post operative infection, pediatric, cefazolin
Brief summary
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.
Detailed description
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.
Interventions
DRUGCefazolin
intravenous cefazolin is being evaluated as a pre-operative prophylactic antibiotic measure with primary outcome being post operative infection rate among participants.
DRUGnormal saline
intravenous normal saline placebo
Sponsors
Legacy Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
'study drug' will be prepared by a participating pharmacist and labeled with a study identification number. The drug will be otherwise not labeled with regard to the arm of the study. This will be delivered to the operating room and administered to the patient. The patient will be entered into a spreadsheet with the study identification number to be used later to evaluate the data. The enrolling/consenting surgeon, and the patient and consenting family member, will be masked to the arm of the study throughout.
Intervention model description
intervention arm of intravenous cefazolin at the time of surgery (standard of care) vs placebo arm of intravenous normal saline at the time of surgery
Eligibility
Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Closed, isolated extension type supracondylar humerus fracture, Gartland type 2, 3, or 4
Exclusion criteria
* Inability to secure consent * Open fractures * Polytrauma * Pathologic fractures * Flexion type fracture * Associated compartment syndrome * Allergy to cefazolin which precludes its use * Skeletally mature patients or patients greater than 18 years of age * Medical comorbidities including immunocompromised state, active infection, and any associated bone, endocrine, or neoplastic conditions contributing to local or generalized abnormal bone mineralization. * Inability to attain satisfactory reduction and fixation via closed manipulation, resulting in conversion to open reduction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| deep post operative infection | 3 months post intervention/surgery | rate of deep post operative infections at the surgical site, requiring treatment including possible hospital admission, intravenous antibiotics, or surgical intervention |
| superficial post operative infection | 3 months post intervention/surgery | rate of superficial post operative infections at the surgical site, requiring treatment limited to oral antibiotics, local wound care, pin removal, or cast change/removal |
Countries
United States
Contacts
Primary ContactJustin N Brohard, DO
Backup ContactBob Umberhandt, MD
Outcome results
None listed