Clinical trial NCT03261830: Antibiotics Usage in Pediatric Orthopaedic Percutaneous Surgery (APOPS)
Official title: Antibiotics Usage in Pediatric Orthopaedic Percutaneous Surgery (APOPS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Supracondylar Humerus Fracture
Post Operative Wound Infection
Keywords: Antibiotic
Pediatric
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: University of Missouri-Columbia
First posted: 2017-08-25
Enrollment: 160
Sex: ALL
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized in that one group receives one dose of pre-operative antibiotics or one that does not.
Primary purpose: PREVENTION

Brief summary: The aim of this study is to determine if antibiotics affect the outcome after percutaneous surgery for pediatric supracondylar humerus fractures. The patient population will be recruited from the cohort presenting to Women and Children's Hospital for percutaneous fixation of pediatric supracondylar humerus fractures who meet the eligibility criteria and consent to taking part in the study. Patients will be followed up for 3-6 weeks depending on age, and will be evaluated on the presence or absence superficial or deep infection, Visual Analog Scale pain scores, time to healing, need for repeat casting, and loss of fixation.

Detailed description: This patient population will be recruited from the cohort presenting to Women and Children's Hospital for percutaneous fixation of pediatric supracondylar humerus fractures. Participants will be asked to assent to take part in the study and their parents or guardian will be asked to sign an informed consent. Patients will be randomized to a treatment group that receives one dose of pre-operative antibiotics or one that does not. Patients randomized to preoperative antibiotics will receive 25mg/kg cefazolin IV up to 1g or clindamycin 10mg/kg up to 600mg IV in cases of documented allergy to cefazolin. Patients randomized to the no-antibiotic group will receive a saline placebo. The resident, anesthesiologist, circulating nurse and other operating room staff will be instructed to not reveal the patient's randomization to the attending physician so as not to interfere with blinding.

The patient will then undergo closed reduction percutaneous pinning of supracondylar humerus fracture. Final AP and lateral fluoroscopic images in the case will be taken. The patient will be discharged from the hospital when pain is controlled with standard oral pain medications and all goals of inpatient management have been achieved. No patients will receive post-operative antibiotics regardless of randomization group as is the existing standard of care. Patients will be scheduled to follow up in 3-6 weeks depending on age. At that time the cast will be removed and AP and lateral radiographs will be used to assess healing. The pins will be removed in clinic and a soft dressing applied to the elbow region.

In cases of excessive pain or cast loosening the patient may be seen in clinic earlier with radiographs and physical exam as indicated. If the attending physician determines that a deep or superficial infection is present at any time during the treatment period the patient will be categorized as infected. If no infection is detected at an earlier-scheduled appointment the patient will be recasted and instructed to follow up as previously scheduled.

Eligibility criteria: Inclusion Criteria:

* Age\<14 years
* Open growth plates
* Gartland type II or III extension type fracture of the distal humerus OR Flexion type fracture of the distal humerus

Exclusion Criteria:

* Need for open reduction
* Need for antibiotics due to other injuries or conditions during the entire study period
* Immunosuppression
* History of malignancy or metabolic bone disease
* Open fractures
* Pre-existing Infection
* Intra-operative breech of sterile technique

Primary outcomes:
measure: Number of Participants With the Presence of Post-Operative Infection
timeFrame: Six weeks
Secondary outcomes:
measure: Visual Analog Pain Scale
timeFrame: Three to Six Week Follow Up
measure: Fractures Fully Healed
timeFrame: Three to Six Week Follow Up
measure: Number of Participants With a Need for Repeat Casting
timeFrame: Three to Six Weeks Follow Up
measure: Number of Participants Experiencing Loss of Fixation
timeFrame: Three to Six Weeks Follow Up
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Health System
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Sumit Gupta, MD
role: PRINCIPAL_INVESTIGATOR
References: