Supracondylar Pinning Antibiotic Stewardship (SPAS) Trial

Legacy Health System

Status: Unknown

Conditions: Infection; Supracondylar Humerus Fracture

Treatments: Drug: Cefazolin; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04288206

SPAS Trial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

1,200 participants in 2 patient groups, including a placebo group

Placebo control

Placebo Comparator group

Description:

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.

Treatment:

Drug: normal saline

Cefazolin prophylaxis

Active Comparator group

Description:

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.

Treatment:

Drug: Cefazolin