Antibiotics Usage in Pediatric Orthopaedic Percutaneous Surgery (APOPS)

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.

Study Overview

• Status: Completed
• Conditions: Supracondylar Humerus Fracture; Post Operative Wound Infection
• Intervention / Treatment: Drug: Cefazolin; Drug: Saline; Drug: Clindamycin

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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 13 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pre-operative Antibiotics; 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.	Drug: Cefazolin; Primary intervention; Drug: Clindamycin; For use in Pre-operative Antibiotics arm in cases of documented allergy to primary intervention.
Placebo Comparator: Saline Placebo; Patients randomized to the no-antibiotic group will receive a saline placebo. This placebo will consist of a 10 mL pre-filled syringe of normal saline.	Drug: Saline; Placebo Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With the Presence of Post-Operative Infection	The primary outcome measure will be the presence of infection as judged by the blinded attending surgeon at the time of cast removal. A superficial infection is defined as a clinical diagnosis based on increased erythema, granulation tissue or purulence at the pin sites that resolves with a short course of oral antibiotics. A deep infection is defined as the presence of septic arthritis or osteomyelitis requiring return to the operating room for debridement or a prolonged course of IV antibiotics. 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.	Six weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Pain Scale	Presented as a 100mm horizontal line on which the patient's pain intensity is represented by a point between two extremes of "no pain at all" = 0 and "worst pain imaginable" = 100.	Three to Six Week Follow Up
Fractures Fully Healed	Time to healing/fractures fully healed was measured by the review of AP and Lateral radiographs at the first follow-up and considered healed if at least 3 cortices had callus. This outcome measure is reported as the number of participants in each group with fully healed fractures at the designated time point.	Three to Six Week Follow Up
Number of Participants With a Need for Repeat Casting	The need for repeat casting can be due to excessive pain or loosening of the cast.	Three to Six Weeks Follow Up
Number of Participants Experiencing Loss of Fixation	Loss of fixation (stabilization) refers to a situation where the fixation of the fracture become compromised.	Three to Six Weeks Follow Up

Collaborators and Investigators

• Sponsor: Sumit Gupta
• Collaborators: University of Missouri-Columbia
• Investigators: Principal Investigator: Sumit Gupta, MD, University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2017
• Primary Completion (Actual): March 10, 2023
• Study Completion (Actual): March 10, 2023

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: August 23, 2017
• First Posted (Actual): August 25, 2017

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Pediatric; Antibiotic
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Fractures, Bone; Wounds and Injuries; Arm Injuries; Surgical Wound; Surgical Wound Infection; Wound Infection; Humeral Fractures; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Cefazolin
• Other Study ID Numbers: 2008610

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No