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Antibiotics Usage in Pediatric Orthopaedic Percutaneous Surgery (APOPS)

NCT03261830 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-08-09

Study results available
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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.

Conditions

  • Supracondylar Humerus Fracture
  • Post Operative Wound Infection

Interventions

DRUG

Cefazolin

Primary intervention

DRUG

Clindamycin

For use in Pre-operative Antibiotics arm in cases of documented allergy to primary intervention.

DRUG

Saline

Placebo Intervention

Sponsors & Collaborators

  • University of Missouri-Columbia

    collaborator OTHER

  • Sumit Gupta

    lead OTHER

Principal Investigators

  • Sumit Gupta, MD · University of Missouri-Columbia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-18
Primary Completion
2023-03-10
Completion
2023-03-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03261830 on ClinicalTrials.gov