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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 : November 1, 2018
Sponsor:
Collaborator:
University of Missouri-Columbia
Information provided by (Responsible Party):
Sumit Gupta, University of Missouri-Columbia

Brief 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, VAS pain scores, time to healing, need for repeat casting, and loss of fixation.

Condition or disease Intervention/treatment Phase
Supracondylar Humerus Fracture Post Operative Wound Infection Drug: Cefazolin Drug: Clindamycin Drug: Saline Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
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.
Primary Purpose: Prevention
Official Title: Antibiotics Usage in Pediatric Orthopaedic Percutaneous Surgery (APOPS)
Actual Study Start Date : August 18, 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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-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.
Drug: Saline
Placebo Intervention




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Pain [ Time Frame: Six weeks ]
    VAS Pain Score



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Lasun O Oladeji, MD (573) 882-7615 oladejil@health.missouri.edu
Contact: John R Worley, MD (573) 884-0645 worleyjr@health.missouri.edu

Locations
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United States, Missouri
University of Missouri Health System Recruiting
Columbia, Missouri, United States, 65212
Contact: Susan Kady, BSN, RN         
Sponsors and Collaborators
Sumit Gupta
University of Missouri-Columbia
Investigators
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Principal Investigator: Sumit Gupta, MD University of Missouri-Columbia

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Responsible Party: Sumit Gupta, Professor, Assistant Clinical - Department of Orthopaedic Surgery, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT03261830     History of Changes
Other Study ID Numbers: 2008610
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sumit Gupta, University of Missouri-Columbia:
Antibiotic
Pediatric
Additional relevant MeSH terms:
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Wound Infection
Surgical Wound Infection
Humeral Fractures
Surgical Wound
Infection
Arm Injuries
Wounds and Injuries
Fractures, Bone
Postoperative Complications
Pathologic Processes
Anti-Bacterial Agents
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Cefazolin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action