Antibiotics Usage in Pediatric Orthopaedic Percutaneous Surgery (APOPS)

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03261830
Study type	Interventional
Source	University of Missouri-Columbia
Contact
Status	Completed
Phase	Phase 4
Start date	August 18, 2017
Completion date	March 10, 2023

View Details

See also
Status	Clinical Trial	Phase
Enrolling by invitation	`NCT05640674` - Post-operative Pain Management in Children With Supracondylar Humerus Fractures	Phase 4
Not yet recruiting	`NCT05501834` - Anxiety Surrounding Supracondylar Pin Removal in Children: A Randomized Controlled Trial	N/A
Not yet recruiting	`NCT05780398` - Long Term Follow up in Pediatric Supracondylar Humeral Fracture
Completed	`NCT00871793` - Effect of Occupational Therapy on the Function and Mobility of Elbow Fractures	N/A
Terminated	`NCT04905563` - NSAIDs vs Opioids for Post-op Pain in Supracondylar Humerus Fractures	Phase 4
Recruiting	`NCT04288206` - Supracondylar Pinning Antibiotic Stewardship (SPAS) Trial	N/A
Completed	`NCT04582123` - Comparison of Cross Pin Configurations in Supracondylar Humerus Fracture Treatment: 2 Pins Versus 3 Pins	N/A
Completed	`NCT04780308` - Pediatric Type III Supracondylar Humeral Fracture
Recruiting	`NCT03759028` - Supracondylar Post-Operative Pain Study	Phase 4
Completed	`NCT01808183` - Pediatric Supracondylar Humerus Fracture NIRS Study
Recruiting	`NCT04122781` - Treatment of Pediatric Supracondylar Humeral Fractures With Novel Kirschner Wire Fixation Devices	N/A
Enrolling by invitation	`NCT06187584` - SCHF Post-Op Study Between Opioid and Non-Opioid Pain Management	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.