Supracondylar Pinning Antibiotic Stewardship (SPAS) Trial
- Conditions
- InfectionSupracondylar Humerus Fracture
- Interventions
- Drug: normal saline
- Registration Number
- NCT04288206
- Lead Sponsor
- Legacy Health System
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1200
- Closed, isolated extension type supracondylar humerus fracture, Gartland type 2, 3, or 4
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo control normal saline Patient will receive 'study drug' which is comprised of 300 mL of normal saline without any medication/antibiotic, which will be delivered by intravenous means at the time of surgery. Cefazolin prophylaxis Cefazolin Patient will receive 'study drug' which is comprised of weight-based dose of cefazolin mixed in 300 mL of normal saline, which will be delivered by intravenous means at the time of surgery.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Legacy Emanuel Medical Center
🇺🇸Portland, Oregon, United States