Antibiotics Usage in Pediatric Orthopaedic Percutaneous Surgery (APOPS)
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|ClinicalTrials.gov Identifier: NCT03261830|
Recruitment Status : Recruiting
First Posted : August 25, 2017
Last Update Posted : December 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|Supracondylar Humerus Fracture Post Operative Wound Infection||Drug: Cefazolin Drug: Clindamycin Drug: Saline||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients will be randomized in that one group receives one dose of pre-operative antibiotics or one that does not.|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||Randomization envelops will be created. Attending surgeons/Investigators will be blinded. Participant will be blinded.|
|Official Title:||Antibiotics Usage in Pediatric Orthopaedic Percutaneous Surgery (APOPS)|
|Actual Study Start Date :||August 18, 2017|
|Estimated Primary Completion Date :||August 2025|
|Estimated Study Completion Date :||December 2025|
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.
For use in Pre-operateive 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.
- Presence of Post-Operative Infection [ Time Frame: Six weeks ]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.
- Visual Analog Scale: Pain Score [ Time Frame: Six weeks ]Subjects rate their pain on a Visual Analog Scale Pain Score from 0-10. 0 being no pain and 10 being the worst pain imaginable.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03261830
|Contact: Lasun O Oladeji, MD||(573) firstname.lastname@example.org|
|Contact: John R Worley, MD||(573) email@example.com|
|United States, Missouri|
|University of Missouri Health System||Recruiting|
|Columbia, Missouri, United States, 65212|
|Contact: Susan Kady, BSN, RN|
|Principal Investigator:||Sumit Gupta, MD||University of Missouri-Columbia|