Phase 4
N=160
Antibiotics Usage in Pediatric Orthopaedic Percutaneous Surgery (APOPS)
Supracondylar Humerus Fracture · Post Operative Wound Infection
Bottom Line
View on ClinicalTrials.gov: NCT03261830 ↗Enrolled (actual)
160
Serious AEs
0.6%
Results posted
Aug 2024
Primary outcome: Primary: Number of Participants With the Presence of Post-Operative Infection — 2; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Cefazolin (Drug); Clindamycin (Drug); Saline (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Sumit Gupta
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With the Presence of Post-Operative Infection |
2; 2 | — |
| SECONDARY Visual Analog Pain Scale |
— | — |
| SECONDARY Fractures Fully Healed |
82; 78 | — |
| SECONDARY Number of Participants With a Need for Repeat Casting |
0; 0 | — |
| SECONDARY Number of Participants Experiencing Loss of Fixation |
0; 0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03261830). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.