CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 160 enrolled
Drug / intervention
Cefazolin +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03261830
NCT03261830Phase 4Completed

Antibiotics Usage in Pediatric Orthopaedic Percutaneous Surgery (APOPS)

Sumit Gupta·interventional·Posted Aug 25, 2017·Updated Aug 9, 2024

In Brief

A Phase 4 clinical trial evaluating Cefazolin, Clindamycin, and 1 other intervention for Supracondylar Humerus Fracture and Post Operative Wound Infection. Completed, enrolled 160 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedAug 25, 2017
Enrollment StartAug 18, 2017
Primary CompletionMar 10, 2023
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 8.9 years ago

Interventions

Cefazolindrug

Primary intervention

Clindamycindrug

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

Salinedrug

Placebo Intervention